Transseptal versus retrograde approach for ablation of left-sided accessory pathways: impact on radiation exposure.

Management of left-sided accessory pathways (APs) is based on catheter ablation through an antegrade or retrograde approach. Both are safe and effective but are associated with exposure to x-rays; however, recipients of ablation are generally young. We sought to evaluate the impact of the approach chosen on dose-area product (DAP). A total of 95 patients who underwent radiofrequency ablation of a left-sided AP between January 2011 and January 2020 were included. The primary endpoint was the radiation dose received by the patient. Secondary endpoints were procedural success and complication and recurrence rates. The mean age of the study population was 34.3 ± 16.6 years. The antegrade transseptal approach was used in 63.5% of cases. By multivariate analysis, the antegrade transseptal approach was associated with a 53% reduction in DAP (p< 0.001). The radiation dose received was also significantly associated with body mass index and total fluoroscopy time (p< 0.001). There was no significant difference in other secondary endpoints between approaches. The use of an antegrade transseptal approach is associated with a significant reduction in DAP compared with the retrograde approach, and procedural success and complication and recurrence rates are similar.

Incidence, predictors, and clinical impact of bleeding recurrence in patients with prior gastrointestinal bleeding undergoing LAAC.

BACKGROUND: Gastrointestinal bleeding (GIB) is associated with a high recurrence rate and a prior GIB episode is common in real-world left atrial appendage closure (LAAC) recipients. The present study sought to evaluate the clinical characteristics and outcomes of patients with prior GIB undergoing LAAC, and to determine the factors associated with and clinical impact of GIB recurrence. METHODS: Multicenter study including 277 consecutive patients who underwent percutaneous LAAC and had prior GIB. All-cause death, all bleeding, GIB recurrence, and clinical ischemic stroke were recorded. RESULTS: After a median follow-up of 17 (interquartile range: 6-37) months post-LAAC, the rates of death, bleeding, GIB recurrence, and ischemic stroke were 14.0 per 100 person-year (PY), 29.3 per 100 PY, 17.7 per 100 PY, and 1.1 per 100 PY, respectively. GIB recurrence occurred within 3 months post-LAAC in 55.8% of patients. A previous lower GIB (vs. upper or unclassified) (HR: 1.76; 95% CI: 1.09-2.82; p = .020) and eGFR < 45 mL/min (HR: 1.70; 95% CI:1.04-2.67; p = .033) determined an increased risk of GIB recurrence. By multivariable analysis, eGFR < 45 mL/min (HR: 2.72; 95% CI: 1.70-4.34; p < .001), GIB recurrence following LAAC (HR: 2.15; 95% CI: 1.33-3.46; p = .002), diabetes mellitus (HR: 1.77; 95% CI: 1.10-2.84; p = .018), and age (HR: 1.06; 95% CI: 1.03-1.10; p < .001) were associated with an increased mortality. CONCLUSIONS: Patients with prior GIB undergoing LAAC exhibited a relatively low rate of GIB recurrence, and prior lower GIB and moderate-to-severe chronic kidney disease determined an increased risk. GIB recurrence was associated with an increased mortality.

Safety and effects of volume loading during transesophageal echocardiography in the pre-procedural work-up for left atrial appendage closure.

BACKGROUND: In patients undergoing left atrial appendage (LAA) closure, an accurate sizing of the LAA is key to optimize device sizing, procedural success and reduce complications. Previous studies have shown that intraprocedural volume loading increases LAA dimensions and improves device sizing. However, the safety and effects on LAA and device sizing of administering a fluid bolus during pre-procedural transesophageal echocardiography (TEE) are unknown. The aim of this study was to determine the safety and impact on LAA dimensions and device sizing of an intravenous (IV) fluid bolus administered during TEE in the setting of the pre-procedural work-up for LAA closure. METHODS: The study included a total of 72 patients who underwent TEE to assess suitability for LAAC and received a 500 ml IV bolus of normal saline. The LAA landing zone (LZ) and depth were measured by TEE before and after volume loading, and these measurements were used to predict the device size implanted during a subsequent percutaneous LAAC procedure. RESULTS: There were no complications associated with volume loading. The baseline mean LZ was 19.6 ± 3.6 mm at 90o, and 20.2 ± 4.1 mm at 135o. Following fluid bolus, the maximum diameter increased 1.5 ± 1.0 mm at 90o (p<0.001), and 1.3 ± 1.0 mm at 135o (p<0.001). The baseline mean depth of the LAA was 26.5 ± 5.5 mm at 90o, and 23.9 ± 5.8 mm at 135o. After fluid bolus, the mean depth increased by 1.5 ± 1.8 mm (p<0.001) and 1.6 ± 2.0 (p<0.001), at 90o and 135o, respectively. Sizing based on post-bolus measurements of the LZ significantly improved the agreement with the final device size selection during the procedure in 71.0% of cases (vs. 42.0% with pre-bolus measurements). CONCLUSIONS: Volume loading during ambulatory TEE as part of the pre-procedural work-up of LAAC is safe and significantly increases LAA dimensions. This strategy may become the new standard, particularly in centers performing LAAC with no TEE guidance, as it improves LAA sizing and more accurately predicts the final device size.

Clinical impact of conduction disturbances in transcatheter aortic valve replacement recipients: a systematic review and meta-analysis.

AIMS: The clinical impact of new-onset persistent left bundle branch block (NOP-LBBB) and permanent pacemaker implantation (PPI) on transcatheter aortic valve replacement (TAVR) recipients remains controversial. We aimed to evaluate the impact of (i) periprocedural NOP-LBBB and PPI post-TAVR on 1-year all-cause death, cardiac death, and heart failure hospitalization and (ii) NOP-LBBB on the need for PPI at 1-year follow-up. METHODS AND RESULTS: We performed a systematic search from PubMed and EMBASE databases for studies reporting raw data on 1-year clinical impact of NOP-LBBB or periprocedural PPI post-TAVR. Data from 30 studies, including 7792 patients (12 studies) and 42 927 patients (21 studies) for the evaluation of the impact of NOP-LBBB and PPI after TAVR were sourced, respectively. NOP-LBBB was associated with an increased risk of all-cause death [risk ratio (RR) 1.32, 95% confidence interval (CI) 1.17-1.49; P < 0.001], cardiac death (RR 1.46, 95% CI 1.20-1.78; P < 0.001), heart failure hospitalization (RR 1.35, 95% CI 1.05-1.72; P = 0.02), and PPI (RR 1.89, 95% CI 1.58-2.27; P < 0.001) at 1-year follow-up. Periprocedural PPI after TAVR was associated with a higher risk of all-cause death (RR 1.17, 95% CI 1.11-1.25; P < 0.001) and heart failure hospitalization (RR 1.18, 95% CI 1.03-1.36; P = 0.02). Permanent pacemaker implantation was not associated with an increased risk of cardiac death (RR 0.84, 95% CI 0.67-1.05; P = 0.13). CONCLUSION: NOP-LBBB and PPI after TAVR are associated with an increased risk of all-cause death and heart failure hospitalization at 1-year follow-up. Periprocedural NOP-LBBB also increased the risk of cardiac death and PPI within the year following the procedure. Further studies are urgently warranted to enhance preventive measures and optimize the management of conduction disturbances post-TAVR.

Timing and evolution of advanced conduction disturbances in patients with right bundle branch block undergoing transcatheter aortic valve replacement.

AIMS: This study sought to determine the timing and evolution over time of advanced conduction disturbances (CDs) in patients with baseline right bundle branch block (RBBB) undergoing transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: One hundred and ten consecutive patients with pre-existing RBBB were included (out of 1341, 8.2%). All arrhythmias during the hospitalization period were recorded. Follow-up was performed at 30 days, 1 year, and yearly thereafter. Conduction recovery and ventricular pacing percentage (VPP) was evaluated at 30 days in those patients with permanent pacemaker implantation (PPMI). Sixty-one (55.5%) patients suffered advanced CDs [97% complete or high-degree atrioventricular block (CHB/HAVB)], and the vast majority (98%) occurred within the first 3 days post-procedure (intraprocedural: 85%). Fifty-two (47.3%) patients had PPMI (vs. 11.0% in non-RBBB patients, P < 0.001). Ventricular pacing percentage at 1 month was higher in patients with persistent-intraprocedural CHB/HAVB compared to those with transient-intraprocedural or post-procedural CHB/HAVB [99 (interquartile range, IQR 97-100)% vs. 72 (IQR 30-99)%, P = 0.02]. Complete recovery (VPP < 1%) was observed in only one patient (2%) with CHB/HAVB. After hospital discharge, no symptomatic bradyarrhythmias or sudden death occurred within 30 days. Patients with pre-existing RBBB exhibited a higher risk of PPMI at 4-year follow-up (26% vs. 8% in non-RBBB patients, P < 0.001). CONCLUSION: In patients with pre-existing RBBB, the vast majority of advanced CDs occurred within the 3 days following TAVR, and most did not recover at 1-month, particularly those with intra-procedural persistent CHB/HAVB. These results should help to determine the hospitalization length and timing of PPMI in RBBB patients undergoing TAVR.

Impact of cardiac resynchronisation therapy on cardiologists' exposure to radiation during implantation of pacemakers and implantable cardioverter-defibrillators.

Cardiologists are among the health professionals that are most exposed to ionizing radiation, but there is no recent study quantifying overexposure of physicians during cardiac resynchronisation therapy (CRT) procedures compared to 'classical' implantation of pacemakers (PMs) or implantable cardioverter-defibrillators (ICDs). We aimed to measure and compare operator exposure to radiation during implantation of PM and ICD with or without CRT. The study population comprised all PMs and ICDs implanted in a large referral centre over a six months period. The endpoint was operator radiation exposure, assessed using a personal electronic dosimeter located on operator's chest. In total, 169 PM/ICD implantations were analysed, 19 of which included CRT. Compared with 'classical' implantation, cardiologist radiation exposure was 9-fold greater during CRT procedures (p < 0.001). Physician exposure was related to dose-area product (R2 = 0.21 during 'classical' implantations and R2 = 0.57 during CRT procedures). Our study shows that cardiologists' exposure to radiation during CRT implantation was 9-fold greater than during procedures without CRT.

Minimizing exposure to radiation in invasive cardiology using modern dose-reduction technology: Evaluation of the real-life effects.

OBJECTIVES: We aimed to measure the reduction in the estimated dose of radiation received by patients that can be achieved using dose-reduction technology (ClarityIQ, Philips Healthcare, The Netherlands), among all patients undergoing invasive cardiology procedures. BACKGROUND: Medical procedures remain the primary source of exposure to ionizing radiation in the general population. METHODS: The study population comprised all patients (without exclusion criteria) undergoing invasive coronary procedures over a 1-year study period in a large referral centre equipped with two catheterization laboratories (cathlabs). Both cathlabs (A and B) were equipped with the Allura Xper FD10 imaging system (Philips Healthcare, The Netherlands), but only Cathlab B was equipped with ClarityIQ technology. The primary endpoint was the estimated total dose of radiation received by the patient, as assessed by Air Kerma (AK) and dose area product (DAP). RESULTS: In total, 2095 invasive coronary procedures were analyzed. The patients who underwent procedures in Cathlab B received an average estimated dose that was 23% (AK) and 43% (DAP) lower than the dose received by patients undergoing procedures in Cathlab A (P < .0001). The reduction remained significant by multivariate analysis after adjustment for total X-ray time, body mass index, arterial approach, PCI of at least one lesion, sex, and patient age. CONCLUSION: In our study, the ClarityIQ technology reduced the estimated radiation dose received by patients by 23-43%, according to the method of measurement.

Clinical impact of complex percutaneous coronary intervention in the pre-TAVR workup.

INTRODUCTION AND OBJECTIVES: In patients undergoing percutaneous coronary intervention (PCI) in the workup pre-transcatheter aortic valve replacement (TAVR), the clinical impact of coronary revascularization complexity remains unknown. This study sought to examine the impact of PCI complexity on clinical outcomes after TAVR in patients undergoing PCI in the preprocedural workup. METHODS: This was a multicenter study including consecutive patients scheduled for TAVR with concomitant significant coronary artery disease. Complex PCI was defined as having at least 1 of the following features: 3 vessels treated, ≥ 3 stents implanted, ≥ 3 lesions treated, bifurcation with 2 stents implanted, total stent length >60mm, or chronic total occlusion. The rates of major adverse cardiac events (MACE), including cardiovascular mortality, myocardial infarction, and coronary revascularization were evaluated. RESULTS: A total of 1550 patients were included, of which 454 (29.3%) underwent complex PCI in the pre-TAVR workup. After a median follow-up period of 2 [1-3] years after TAVR, the incidence of MACE was 9.6 events per 100 patients-years. Complex PCI significantly increased the risk of cardiac death (HR, 1.44; 95%CI, 1.01-2.07), nonperiprocedural myocardial infarction (HR, 1.52; 95%CI, 1.04-2.21), and coronary revascularization (HR, 2.46; 95%CI, 1.44-4.20). In addition, PCI complexity was identified as an independent predictor of MACE after TAVR (HR, 1.31; 95%CI, 1.01-1.71; P=.042). CONCLUSIONS: In TAVR candidates with significant coronary artery disease requiring percutaneous treatment, complex revascularization was associated with a higher risk of MACE. The degree of procedural complexity should be considered a strong determinant of prognosis in the PCI-TAVR population.

The Management of Coronary Artery Disease in TAVR Patients.

About half of the transcatheter aortic valve replacement (TAVR) recipients exhibit some degree of coronary artery disease (CAD), and controversial results have been reported regarding the impact of the presence and severity of CAD on clinical outcomes post-TAVR. In addition to coronary angiography, promising data has been recently reported on the use of both cardiac computed tomography angiography and the functional invasive assessment of coronary lesions whether by FFR or iFR in the work-up pre-TAVR. Despite mitigated available data, percutaneous revascularization of significant coronary lesions has been the routine strategy in TAVR candidates with CAD. Additionally, scarce data exists on the incidence, characteristics and management of coronary events post-TAVR, and increasing interest exists on the potential coronary access challenges in patients requiring coronary angiography/intervention post-TAVR. This review provides an updated overview of the knowledge of CAD in TAVR recipients, focusing on its prevalence, clinical impact, pre- and post-procedural evaluation and management.

Relationship between Exercise Test Parameters, Device-Delivered Electric Shock and Adverse Clinical Events in Patients with an Implantable Cardioverter Defibrillator for Primary Prevention.

(1) Background: Receiving the first internal electric shock is a turning point for patients with an implantable cardioverter defibrillator (ICD) for primary prevention. However, no study has investigated whether patients who receive a first device-delivered electric shock have a poor prognosis even at the time of ICD implantation. (2) Methods: We retrospectively identified 55 patients with ischemic (n = 31) or dilated (n = 24) cardiomyopathy who underwent ICD implantation for primary prevention with exercise test at the time of implantation. We recorded baseline characteristics, exercise test parameters, and clinical events. (3) Results: After a median follow-up of 5 years, we observed an association between an appropriate device-delivered electric shock, the occurrence of death or heart transplant, and the occurrence of the composite endpoint. There was also a significant relation between a VE/VCO2 slope >35 and the occurrence of the composite endpoint. Conversely, there was no significant association between negative outcomes on the exercise test and the occurrence of a device-delivered electric shock. (4) Conclusions: The exercise test performed at the time of ICD implantation do not predict the occurrence of device-delivered electric shock. The exercise test and the first electric shock are two independent markers of poor prognosis.

Left atrial dissection after a supra-annular mitral valve replacement for endocarditis.

BACKGROUND: Left atrial dissection is a rare and a potentially fatal complication of cardiac surgery. Multi-modal imagery is helpful for the diagnosis and to guide the treatment. CASE PRESENTATION: We report the case of a 66-year-old female patient who underwent a combined mitral and aortic valve replacement for degenerative valvular disease. She presented an infectious endocarditis revealed by a third-degree atrioventricular bloc and had a redo mitral- and aortic valve replacement. Mitral valve was inserted in supra-annular position due to annular destruction. Post-operative course was marked by a refractory acute heart failure explained by a left atrial wall dissection confirmed by transoesophageal echocardiography and synchronized cardiac CT-scan. Surgical treatment was theoretically indicated but considering the high risk of a third surgery, a palliative care support was collegially decided. CONCLUSIONS: Left atrial dissection can occur after a redo surgery and supra-annular mitral valve implantation. Multi-modal imagery including transoesophageal echocardiography and cardiac CT-scan is helpful for the diagnosis.

Catheter versus surgical approach for the management of concomitant aortic stenosis and coronary artery disease: An inverse probability treatment weighting analysis.

BACKGROUND: Two therapeutic strategies are available when aortic stenosis and coronary artery disease coexist: a transcatheter approach, with percutaneous coronary intervention followed by transcatheter aortic valve replacement; and a surgical approach, consisting of surgical aortic valve replacement combined with coronary artery bypass graft. AIM: We sought to compare the outcomes of these two strategies. METHODS: The study population consisted of 241 patients who benefited from aortic valve replacement and coronary revascularization (transcatheter, n=150; surgery, n=91). RESULTS: Patients in the transcatheter population were older (83.5 vs. 71.8years; P<0.001) and had a higher Logistic EuroSCORE (11.1% vs. 5.7%; P<0.001). At 30days postprocedure, patients who had surgery exhibited more life-threatening bleedings (12.1% vs 4.5%; P=0.034), acute kidney injury (12.1% vs. 1.3%; P<0.001) and atrial fibrillation (55.6% vs. 8.7%; P<0.001). After a median follow-up of 27months, the risk of major adverse cardiovascular or cerebrovascular events did not differ significantly between the two strategies (hazard ratio [HR] 1.41, 95% confidence interval [CI] 0.97-2.04; P=0.07), whereas estimated glomerular filtration rate<60mL/min (HR 2.22, 95% CI 1.58-3.12; P<0.001), peripheral artery disease (HR 2.00, 95% CI 1.37-2.91; P<0.001) and left ventricular ejection fraction<50% (HR 1.69, 95% CI 1.12-2.55; P=0.012) were associated with a negative prognosis. CONCLUSIONS: In our study, patients with aortic stenosis and coronary artery disease treated by catheter were older and had a higher co-morbidity burden than those treated by surgery. The surgical strategy was associated with a higher rate of 30-day complications, but long-term outcomes were similar between the two strategies.

Fractional Flow Reserve to Assess Coronary Artery Disease in Patients with Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation: Long-Term Outcomes.

Background: The long-term outcomes of patients undergoing functional assessment of coronary lesions with fractional flow reserve (FFR) while awaiting transcatheter aortic valve implantation (TAVI) are unknown. Data on the safety of intracoronary adenosine use in this setting are scarce. The objectives of this study were to describe (1) the long-term outcomes based on the coronary artery disease (CAD) assessment strategy used and (2) the safety of intracoronary adenosine in patients with severe aortic stenosis (AS). Methods: 1023 patients with severe AS awaiting TAVI were included. Patients were classified according to their CAD assessment strategy: angiography guided or FFR guided. Patients were further subdivided according to the decision to proceed with percutaneous coronary intervention (PCI): angiography-guided PCI (375/1023), angiography-guided no-PCI (549/1023), FFR-guided PCI (50/1023), and FFR-guided no-PCI (49/1023). Patients were followed up for the occurrence of major adverse cardiac and cerebrovascular events (MACCEs). Results: At a mean follow-up of 33.7 months, we observed no significant differences in terms of major adverse cardiovascular and cerebrovascular events (MACCE) in the angiography-guided group (42.4%) compared with the FFR-guided group (37.4%) (p = 0.333). When comparing outcomes of the FFR-guided no-PCI group (32.7%) with the angiography-guided PCI group (46.4%), no significant difference was noted (p = 0.999). Following intracoronary adenosine, a single adverse event occurred. Conclusions: In this population, intracoronary adenosine is safe and well tolerated. We found no significant benefit to an FFR-guided strategy compared with an angiography-guided strategy with respect to MACCEs. Although clinically compelling, avoiding the procedural risks of PCI by deferring the intervention in functionally insignificant lesions failed to show a statistically significant benefit.

Late Bleeding Events in Patients Undergoing Percutaneous Coronary Intervention in the Workup Pre-TAVR.

BACKGROUND: In patients undergoing percutaneous coronary intervention (PCI) in the work-up pre-transcatheter aortic valve replacement (TAVR), the incidence and clinical impact of late bleeding events (LBEs) remain largely unknown. OBJECTIVES: This study sought to determine the incidence, clinical characteristics, associated factors, and outcomes of LBEs in patients undergoing PCI in the work-up pre-TAVR. METHODS: This was a multicenter study including 1,457 consecutive patients (mean age 81 ± 7 years; 41.5% women) who underwent TAVR and survived beyond 30 days. LBEs (>30 days post-TAVR) were defined according to the Valve Academic Research Consortium-2 criteria. RESULTS: LBEs occurred in 116 (7.9%) patients after a median follow-up of 23 (IQR: 12-40) months. Late bleeding was minor, major, and life-threatening or disabling in 21 (18.1%), 63 (54.3%), and 32 (27.6%) patients, respectively. Periprocedural (<30 days post-TAVR) major bleeding and the combination of antiplatelet and anticoagulation therapy at discharge were independent factors associated with LBEs (P ≤ 0.02 for all). LBEs conveyed an increased mortality risk at 4-year follow-up compared with no bleeding (43.9% vs 36.0; P = 0.034). Also, LBE was identified as an independent predictor of all-cause mortality after TAVR (HR: 1.39; 95% CI: 1.05-1.83; P = 0.020). CONCLUSIONS: In TAVR candidates with concomitant significant coronary artery disease requiring percutaneous treatment, LBEs after TAVR were frequent and associated with increased mortality. Combining antiplatelet and anticoagulation regimens and the occurrence of periprocedural bleeding determined an increased risk of LBEs. Preventive strategies should be pursued for preventing late bleeding after TAVR, and further studies are needed to provide more solid evidence on the most safe and effective antithrombotic regimen post-TAVR in this challenging group of patients.

Persistent and Recurrent Device-Related Thrombus After Left Atrial Appendage Closure: Incidence, Predictors, and Outcomes.

BACKGROUND: Scarce data exist on the evolution of device-related thrombus (DRT) after left atrial appendage closure (LAAC). OBJECTIVES: This study sought to assess the incidence, predictors, and clinical impact of persistent and recurrent DRT in LAAC recipients. METHODS: Data were obtained from an international multicenter registry including 237 patients diagnosed with DRT after LAAC. Of these, 214 patients with a subsequent imaging examination after the initial diagnosis of DRT were included. Unfavorable evolution of DRT was defined as either persisting or recurrent DRT. RESULTS: DRT resolved in 153 (71.5%) cases and persisted in 61 (28.5%) cases. Larger DRT size (OR per 1-mm increase: 1.08; 95% CI: 1.02-1.15; P = 0.009) and female (OR: 2.44; 95% CI: 1.12-5.26; P = 0.02) were independently associated with persistent DRT. After DRT resolution, 82 (53.6%) of 153 patients had repeated device imaging, with 14 (17.1%) cases diagnosed with recurrent DRT. Overall, 75 (35.0%) patients had unfavorable evolution of DRT, and the sole predictor was average thrombus size at initial diagnosis (OR per 1-mm increase: 1.09; 95% CI: 1.03-1.16; P = 0.003), with an optimal cutoff size of 7 mm (OR: 2.51; 95% CI: 1.39-4.52; P = 0.002). Unfavorable evolution of DRT was associated with a higher rate of thromboembolic events compared with resolved DRT (26.7% vs 15.1%; HR: 2.13; 95% CI: 1.15-3.94; P = 0.02). CONCLUSIONS: About one-third of DRT events had an unfavorable evolution (either persisting or recurring), with a larger initial thrombus size (particularly >7 mm) portending an increased risk. Unfavorable evolution of DRT was associated with a 2-fold higher risk of thromboembolic events compared with resolved DRT.

Percutaneous left atrial appendage closure in patients with primary hemostasis disorders and atrial fibrillation.

BACKGROUND OR PURPOSE: We report our single-center experience with percutaneous left atrial appendage closure (LAAC) in patients with non-valvular atrial fibrillation (NVAF) and primary hemostasis disorders (HD). METHODS: Consecutive patients with primary HD who underwent a percutaneous LAAC were included. Baseline characteristics, procedural data, and clinical outcomes were prospectively collected and compared with the overall LAAC cohort without HD. RESULTS: Since 2013, among 229 LAAC, 17 patients (7%) had a primary HD: thrombocytopenia (n = 5), myelodysplastic syndrome (n = 6), von Willebrand syndrome (n = 4), type A hemophilia (n = 1), and dysfibrinogenemia (n = 1). The HD population's age ranged from 61 to 87 years, and the median CHA2DS2VASc was 5. Periprocedural plasmatic management was required in 47% of patients. The immediate LAAC implantation success rate was 100%. Patients received a direct oral anticoagulant (DOA) (n = 9), dual antiplatelet (n = 6), aspirin (n = 1), or no therapy (n = 1) during the first six postoperative weeks, followed with single antiplatelet (n = 16) or no therapy (n = 1) during lifelong. After 20 months, the technical success rate and procedural success rate were 100% and 94%. Zero device-/procedure-related complication and only one life-threatening bleeding occurred. Compared to patients without HD (n = 212), a baseline history of bleeding was less frequent (53% vs 91%, p < 0.001), and more patients received a perioperative blood transfusion (47% vs 4%, p < 0.001) in the HD group. The efficacy and safety outcomes did not differ between HD and non-HD cohorts. CONCLUSIONS: Percutaneous LAAC in primary HD carriers appeared as safe and as effective as in overall LAAC population for stroke and bleeding prevention at midterm follow-up. Percutaneous left atrial appendage closure in patients with atrial fibrillation and primary hemostasis disorders. The percutaneous LAAC in primary hemostasis disorders and AF carriers requires a multidisciplinary approach. Cardiologist, anesthesiologist, and hematologist discussion is a cornerstone to assess anticoagulant contraindication, LAAC feasibility, periprocedural management, and follow-up (high). This multidisciplinary care is illustrated by the case of a 61-year-old male with hemophilia type A and recurrent hemarthrosis. Pre-LAAC assessment confirmed procedural indication and cactus LAA anatomy (left). After plasmatic management with factor VIII infusion, a WATCHMAN™ no. 21 was successfully implanted (middle). During follow-up, without antithrombotic regime, no ischemic or hemorrhagic complication occurred (right). LAA, left atrial appendage; LAAC, left atrial appendage closure; TEE, transesophageal echocardiography. Percutaneous LAAC in primary HD carriers appeared as safe and as effective as in overall LAAC population for stroke and bleeding prevention at midterm follow-up.

Unplanned Hospital Readmissions After Transcatheter Aortic Valve Replacement in the Era of New-Generation Devices.

OBJECTIVES: Unplanned hospital readmissions after transcatheter aortic valve replacement (TAVR) are frequent and have been associated with a poor prognosis. We sought to determine the trends in the incidence and causes of unplanned hospital readmission after TAVR in patients receiving new-generation devices (NGDs) vs early-generation devices (EGDs). METHODS: The study population consisted of 1802 consecutive TAVR recipients (863 EGDs and 939 NGDs). Early and late readmissions were defined as those occurring ≤30 days and >30 days to 1-year post TAVR, respectively. RESULTS: A total of 986 unplanned hospital readmissions (cardiac cause, 38.4%; non-cardiac cause, 61.6%) were recorded at a median time of 110 days (interquartile range [IQR], 37-217) post TAVR. The rates of early (12.3% vs 9.4%; P=.046) and late (39.1% vs 31.6%; P<.01) readmission were lower in the NGD population. In the NGD group, major/life-threatening periprocedural bleeding (hazard ratio [HR], 2.40, 95% confidence interval [CI], 1.06-5.42; P=.04) and estimated glomerular filtration rate (eGFR) <60 mL/min at hospital discharge (HR, 1.80; 95% CI, 1.15-2.83; P=.01) were associated with an increased risk of early readmission post TAVR. Chronic obstructive pulmonary disease (HR, 1.42; 95% CI, 1.07-1.88; P=.02), eGFR <60 mL/min (HR, 1.43; 95% CI, 1.11-1.84; P<.01), and combining antiplatelet and anticoagulation therapy (HR, 1.37; 95% CI, 1.01-1.85; P=.04) determined an increased risk of late readmission. CONCLUSIONS: TAVR recipients receiving NGDs exhibited a significant but modest reduction in unplanned hospital readmissions, with about one-third of patients still requiring rehospitalization at 1-year follow-up in the contemporary TAVR era. Non-cardiac comorbidities, periprocedural bleeding events, and intensive antithrombotic therapy determined an increased risk.

Meta-analysis Comparing Early Outcomes Following Transcatheter Aortic Valve Implantation With the Evolut Versus Sapien 3 Valves.

We aimed to compare the early (in-hospital/30-day) outcomes (major periprocedural complications, device success/valve performance, and mortality) following transcatheter aortic valve implantation with the Sapien 3 versus Evolut transcatheter valve systems. This was a systematic review from PubMed and EMBASE databases for studies reporting raw data or estimates. The outcomes analyzed were (1) in-hospital/30-day major periprocedural complications, (2) device success and valve performance, and (3) mortality. The outcomes were defined according to VARC-2 criteria. A total of 24,628 transcatheter aortic valve implantation patients from 9 studies (1 randomized, 8 observational [5 case- or propensity-matched analyses]) were included: 12,411 and 12,217 patients had Sapien 3 and Evolut valve implantation, respectively. There were no differences between devices regarding in-hospital/30-day stroke (risk ratio [RR] 0.95, 95% confidence interval [CI] 0.34 to 2.66), major vascular complications (RR 1.03, 95% CI 0.63 to 1.68), acute kidney injury (RR 1.17, 95% CI 0.78 to 1.77), device success (RR 1.00, 95% CI 0.97 to 1.04) and moderate-severe residual aortic regurgitation (RR 0.49, 95% CI 0.20 to 1.17). Sapien 3 recipients exhibited lower risk of permanent pacemaker implantation (RR 0.66, 95% CI 0.55 to 0.80), a higher risk of life-threatening bleeding (RR 1.82, 95% CI 1.18 to 2.80), and higher residual transvalvular gradients (mean difference 3.95 mmHg, 95% CI 3.37 to 4.56). A lower risk of in-hospital/30-day mortality was observed for Sapien 3 (RR 0.79, 95% CI 0.69 to 0.90). In conclusion, the similarities in device success rate and major periprocedural complications (except for a higher and lower risk of permanent pacemaker implantation and life-threatening bleeding, respectively, with the Evolut system) support the lack of a valve type effect accounting for the increased mortality risk observed with the Evolut valve.

Transcatheter Interventions for Tricuspid Valve Disease: What to Do and Who to Do It On.

Tricuspid valve disease, and particularly the management of severe tricuspid regurgitation (TR), has gained momentum in recent years. Although it is well known that this frequent condition is associated with poor clinical outcomes, these patients have been classically managed medically, leading to end-stage right ventricular heart failure. Moreover, late referral to surgery has contributed to a high rate of periprocedural complications and in-hospital surgical mortality. Thus, the development of a less invasive catheter-based therapy would be of high clinical relevance in this context. Several transcatheter tricuspid valve intervention (TTVI) devices have been developed in recent years. The particular characteristics of the tricuspid valve (large noncalcific annulus, presence of chief surrounding structures such as the conduction system or the right coronary artery) make multimodality imaging (eg, transesophageal echocardiography, computed tomography) key in the preprocedural assessment of TTVI. According to their mechanism of action and therapeutic target, TTVI includes transcatheter repair either with coaptation or annuloplasty systems, caval valve devices, and transcatheter tricuspid valve replacement. The initial TTVI experience showed that most procedures were well tolerated, with high procedural success and low in-hospital and early mortality. Also, most TTVI recipients improved their functional status and recent data suggest improved outcomes compared with medical management. However, the rate of significant residual TR after transcatheter tricuspid valve repair remains high and very scarce data exist on longer term (beyond 6-12 months) outcomes. The present review provides an overview regarding the framework of chronic TR and TTVI therapeutic options, and describes the updated current evidence in this challenging field.