Incidence, predictors, and prognostic impact of new permanent pacemaker implantation after TAVR with self-expanding valves

OBJECTIVES: The authors sought to evaluate the incidence, predictors, and outcomes of new permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with contemporary self-expanding valves (SEV). BACKGROUND: Need for PPI is frequent post-TAVR, but conflicting data exist on new-generation SEV and on the prognostic impact of PPI. METHODS: This study included 3,211 patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries (January 2012 to December 2021) who underwent transfemoral TAVR with SEV. Implanted transcatheter heart valves (THV) were Acurate neo (n = 1,090), Acurate neo2 (n = 665), Evolut PRO (n = 1,312), and Evolut PRO+ (n = 144). Incidence and predictors of new PPI and 1-year outcomes were evaluated. RESULTS: New PPI was needed in 362 patients (11.3%) within 30 days after TAVR (8.8%, 7.7%, 15.2%, and 10.4%, respectively, after Acurate neo, Acurate neo2, Evolut PRO, and Evolut PRO+). Independent predictors of new PPI were Society of Thoracic Surgeons Predicted Risk of Mortality score, baseline right bundle branch block and depth of THV implantation, both in patients treated with Acurate neo/neo2 and in those treated with Evolut PRO/PRO+. Predischarge reduction in ejection fraction (EF) was more frequent in patients requiring PPI (P = 0.014). New PPI was associated with higher 1-year mortality (16.9% vs 10.8%; adjusted HR: 1.66; 95% CI: 1.13-2.43; P = 0.010), particularly in patients with baseline EF <40% (P for interaction = 0.049). CONCLUSIONS: New PPI was frequently needed after TAVR with SEV (11.3%) and was associated with higher 1-year mortality, particularly in patients with EF <40%. Baseline right bundle branch block and depth of THV implantation independently predicted the need of PPI.

Impact of Right Ventricular Pacing in Patients With TAVR Undergoing Permanent Pacemaker Implantation.

BACKGROUND: Long-term right ventricular pacing (VP) has been related to negative left ventricular remodeling and heart failure (HF), but there is a lack of evidence regarding the prognostic impact on transcatheter aortic valve replacement (TAVR) patients. OBJECTIVES: The aim of the PACE-TAVI registry is to evaluate the association of high percentage of VP with adverse outcomes in patients with pacemaker implantation after TAVR. METHODS: PACE-TAVI is an international multicenter registry of all consecutive TAVR patients who underwent permanent pacemaker implantation for conduction disturbances in the first 30 days after the procedure. Patients were divided into 2 subgroups according to the percentage of VP (<40% vs ≥40%) at pacemaker interrogation. The primary endpoint was the composite of cardiovascular mortality or hospitalization for HF. RESULTS: A total of 377 patients were enrolled, 158 with VP <40% and 219 with VP ≥40%. After multivariable adjustment, VP ≥40% was associated with a higher incidence of the primary endpoint (HR: 2.76; 95% CI: 1.39-5.51; P = 0.004), first HF hospitalization (HR: 3.37; 95% CI: 1.50-7.54; P = 0.003), and cardiovascular death (HR: 3.77; 95% CI: 1.02-13.88; P = 0.04), while the incidence of all-cause death was not significantly different (HR: 2.17; 95% CI: 0.80-5.90; P = 0.13). Patients with VP ≥ 40% showed a higher New York Heart Association functional class both at 1 year (P = 0.009) and at last available follow-up (P = 0.04) and a nonsignificant reduction of left ventricular ejection fraction (P = 0.18) on 1-year echocardiography, while patients with VP <40% showed significant improvement (P = 0.009). CONCLUSIONS: In TAVR patients undergoing permanent pacemaker implantation, a high percentage of right VP at follow-up is associated with an increased risk for cardiovascular death and HF hospitalization. These findings suggest the opportunity to minimize right VP through dedicated algorithms in post-TAVR patients without complete atrioventricular block and to evaluate a more physiological VP modality in patients with persistent complete atrioventricular block.

Temporal Trends and Contemporary Outcomes After Transcatheter Aortic Valve Replacement With Evolut PRO/PRO+ Self-Expanding Valves: Insights From the NEOPRO/NEOPRO-2 Registries.

BACKGROUND: In recent years, transcatheter aortic valve replacement (TAVR) techniques and technology have continuously improved. Data regarding the impact of these advancements on outcomes in large real-world settings are still limited. The aim of this study was to investigate temporal trends and assess contemporary outcomes after TAVR with Evolut PRO/PRO+ supra-annular self-expanding valves. METHODS: This study included patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries who underwent transfemoral TAVR with Evolut PRO/PRO+. Procedural dates (August 2017 through November 2021) were stratified in quartiles (Q) and used to investigate temporal trends in TAVR outcomes. Predischarge, 30-day Valve Academic Research Consortium-3 defined, and 1-year outcomes were evaluated. RESULTS: In total, 1616 patients from 28 centers were included. Over time, patients had lower Society of Thoracic Surgeon-Predicted Risk of Mortality score (Q1-4, 4.1% [2.8-6.3%], 3.7% [2.6-5.3%], 3.3% [2.4-4.9%], 2.9% [2.2-4.3%]; P<0.001) and more moderate or heavy valve calcification (Q1-4, 80%, 80%, 82%, 88%; P=0.038). Overall Valve Academic Research Consortium-3 technical success was 94.1%, with 30-day and 1-year all-cause mortality of 2.4% and 10%, respectively. Throughout the study period, procedures were associated with higher rates of 30-day device success (Q1-4, 81.2%, 82.2%, 82.0%, 88.0%; Cochran-Armitage P=0.023) and early safety (Q1-4, 66.8%, 67.5%, 74.0%, 77.6%; Cochran-Armitage P<0.001), with fewer permanent pacemaker implantations (Q1-4: 15.3%, 20.0%, 12.1%, 11.6%; Cochran-Armitage P=0.023) and residual mild or greater paravalvular leaks (Q1-4, 50.4%, 42.1%, 36.5%, 35.8%; Cochran-Armitage P<0.001). CONCLUSIONS: TAVR with Evolut PRO/PRO+ self-expanding valve is safe and effective. Despite the treatment of heavier calcified anatomies, procedural outcomes are improving over time with less need for pacemaker implantation and less significant paravalvular leaks.

Comparison of transcatheter aortic valve replacement with the ACURATE neo2 versus Evolut PRO/PRO+ devices.

BACKGROUND: The ACURATE neo2 (NEO2) and Evolut PRO/PRO+ (PRO) bioprostheses are new-generation self-expanding valves developed for transcatheter aortic valve replacement (TAVR). AIMS: We sought to compare the performance of the ACURATE neo2 and Evolut PRO/PRO+ devices. METHODS: The NEOPRO-2 registry retrospectively included patients who underwent TAVR for severe aortic stenosis with either the NEO2 or PRO devices between August 2017 and December 2021 at 20 centres. In-hospital and 30-day Valve Academic Research Consortium (VARC)-3 defined outcomes were evaluated. Propensity score (PS) matching and binary logistic regression were performed to adjust the treatment effect for PS quintiles. A subgroup analysis assessed the impact of aortic valve calcification. RESULTS: A total of 2,175 patients (NEO2: n=763; PRO: n=1,412) were included. The mean age was 82±6.2 years and the mean Society of Thoracic Surgeons score was 4.2%. Periprocedural complications were low, and both groups achieved high rates of technical success (93.1% vs 94.1%; p=0.361) and predischarge intended valve performance (96.0% vs 94.1%; p=0.056), both in the unmatched and matched analysis (452 pairs). Device success at 30 days was comparable (84.3% vs 83.6%; p=0.688), regardless of aortic valve calcification severity (p>0.05 for interaction). A suggestion for higher VARC-3 early safety in the NEO2 group was mainly driven by reduced rates of new permanent pacemaker implantation (7.7% vs 15.6%; p<0.001). CONCLUSIONS: This retrospective analysis reports a similar short-term performance of the ACURATE neo2 platform compared with the new-generation Evolut PRO/PRO+ devices. Randomised studies are needed to confirm our exploratory findings.

When you hear hoofbeats, think zebras - pulmonary veno-occlusive disease: A case report.

Pulmonary veno-occlusive disease (PVOD) is a rare disease. It may be idiopathic or associated, in particular, with connective tissue disease, or it may develop after radiation exposure; in heritable forms of PVOD, the inheritance is autosomal recessive due to the presence of homozygous or compound heterozygous pathogenic variants in the EIF2AK4 gene. We describe the case of a young man whose PVOD was initially misdiagnosed as chronic thromboembolic pulmonary hypertension despite worsening after riociguat, nonspecific computed tomography pulmonary angiogram findings, and parental consanguinity could suggest an autosomal recessive disease. The correct diagnosis and the correct treatment are crucial given the high mortality rate of this disease.

Direct oral anticoagulants or vitamin K antagonists after TAVR: A systematic review and meta-analysis.

BACKGROUND: Several patients undergoing transcatheter aortic valve replacement (TAVR) also require oral anticoagulation (OAC) for atrial fibrillation (AF) or deep vein thromboembolism. However, the optimal type of OAC strategy (direct oral anticoagulants, DOACs, or vitamin K antagonists, VKA) is still unclear in this setting. METHOD: We performed systematic literature research and meta-analysis in PubMed, Medline, and EMBASE databases for studies reporting either all-cause mortality, major/life-threatening bleeding or stroke events. RESULTS: Ten observational studies and two randomized controlled trials (RCTs) including a total of 29,485 patients were eligible for inclusion. Compared to VKA, DOACs use after TAVR was associated with a modest but significantly lower rates of all-cause mortality (RR 0.90; 95% CI: 0.81-0.99, p-value 0.04) with results mainly driven by observational studies. Cardiovascular mortality (RR 1.03; 95% CI: 0.81-1.30; p-value 0.84), total stroke events (RR 0.97; 95% CI: 0.76-1.23, p-value 0.79), major/life-threatening bleeding (RR 0.93; 95% CI: 0.72-1.21, p-value 0.61) and minor bleeding (RR 0.96; 95% CI: 0.74-1.23; p-value 0.72) were similar between VKA and DOACs. CONCLUSION: Considering the totality of available evidence, in patients who underwent TAVR with a concomitant indication for OAC, DOACs-based strategy is an effective and safe anticoagulation strategy compared to VKA.

Pacemaker-Related Complications in Patients Undergoing Transcatheter Aortic Valve Implantation: A Single-Center Experience.

BACKGROUND: The aim of this study was to describe the rate of complications secondary to permanent pacemaker (PPM) implantation after transcatheter aortic valve implantation (TAVI). METHODS: Patients were identified by retrospective review of a dedicated TAVI database at a single center between 2008 and 2015. Clinical and procedural data were collected to determine the incidence and severity of the main adverse events following this procedure. The overall population included 736 patients and 123 (16.7%) underwent PPM implantation. Three patients were excluded from the final analysis due to PPM implantation occurring at other institutions post discharge. The final population consisted of 120 patients (16.3%). RESULTS: Self- and mechanically expandable valves were associated with a higher risk of PPM after TAVI compared with balloon-expandable valves (23.9% vs 27.5% vs 7.6%, respectively; P<.001). Year of procedure and operator's experience did not affect the PPM-related complication rate. A high rate of major bleeding complications (n = 29; 24.1%) was observed. Major bleeding occurred more frequently in patients who received PPM implantation within the first 24 hours post TAVI than in the group of patients who required a PPM >24 hours post TAVI (38.2% vs 12.3%, respectively; P<.01). Patients who experienced a major bleeding event following PPM insertion were more frequently on triple-antithrombotic therapy (51.7% vs 9.9%; P<.001). CONCLUSIONS: PPM-related complications are common in elderly patients after TAVI, and some of these adverse events can be life threatening. Particular attention is required in the periprocedural management of these patients.

Transcatheter Aortic Valve Replacement Outcomes in Patients With Native vs Transplanted Kidneys: Data From an International Multicenter Registry.

BACKGROUND: Chronic kidney disease (CKD) has a negative impact on outcomes after transcatheter aortic valve replacement (TAVR). Data on outcomes in renal transplant recipients (RTRs) undergoing TAVR are scarce. We compared the outcomes in RTRs undergoing TAVR with matched patients who have native kidneys and similar kidney function. METHODS: This retrospective cohort study used data from 16 TAVR centres (13,941 patients). The study cohort included 216 patients (72 RTRs and 144 matched controls). RESULTS: The mean estimated glomerular filtration rate (eGFR) was 39.2 ± 23.6 vs 44.5 ± 23.6 mL/min for RTRs and control patients (P = 0.149), with a similar CKD stage distribution. After TAVR, the eGFR declined among RTRs but remained stable for up to 1 year in controls (P = 0.021). Long-term hemodialysis was required in 19 (26.4%) RTRs and 20 (13.8%) controls (hazard ratio [HR] = 2.09 95% confidence interval [CI], 1.03-3.86; P = 0.039) and was most often initiated during the periprocedural period (14 RTRs vs 16 controls; P = 0.039). After a median follow-up of 2.3 years, risk of death (29.2% vs 31.9%) and death/hemodialysis (40.3% vs 36.8%) was similar between the groups. The contrast volume/eGFR ratio was the strongest predictor of hemodialysis initiation (odds ratio [OR] = 1.64; 95% CI, 1.36-1.97 per 1 unit increase; P < 0.001), with a greater effect among RTRs than controls (P for interaction = 0.022). CONCLUSION: s: TAVR appears safe in RTRs with mortality rates similar to matched patients with native kidneys. However, RTRs carry an increased risk of progressive renal impairment and need for hemodialysis initiation after TAVR. Our data highlight the importance of minimizing contrast load during TAVR, particularly in RTRs.

Diagnostic Accuracy of Microcatheter Derived Fractional Flow Reserve.

Microcatheter derived fractional flow reserve (FFRMC) system has an increased profile compared with pressure-wire derived fractional flow reserve (FFRW). Consequently, the FFRMC system itself may increase the degree of coronary artery stenosis and lower the measured FFR value. This can affect the diagnostic accuracy of the FFRMC system and inadvertently result in erroneous therapy for patients. Our aim was to evaluate the diagnostic accuracy FFRMC measurements and provide a means for clinicians to interpret individual FFRMC results with respect to FFRW. Correlation between FFR measurement techniques was analyzed in this lesion level analysis of 413 patients and 441 lesions from 6 studies. The reference standard to determine physiological significant stenosis was FFRW value ≤0.80. The mean values for FFRMC and FFRW were 0.80 ± 0.11 and 0.83 ± 0.09, respectively. Bland-Altman analysis demonstrated a bias toward overestimation of FFR by FFRMC (bias, -0.03 [0.05]). The overall lesion level diagnostic accuracy of the FFRMC system was 80.4% (95% confidence interval [CI] 76.2% to 84.0%). The diagnostic accuracy for FFRMC values <0.75, 0.75 to 0.85 and >0.85 were 83.7% (95% CI 71.4% to 92.4%), 72.3% (95% CI 59.8% to 75.6%), and 99.2% (95% CI 94.8% to 99.8%), respectively. Using the FFRW threshold of ≤0.80, 16.3% of lesions would have had inappropriate revascularization according to FFRMC measurements. Receiver-operating characteristics suggested the optimal cut-off value of FFRMC to determine ischemia was 0.78. In conclusion, the diagnostic accuracy of FFRMC varies markedly across the spectrum of disease with marked deterioration for values between 0.75 and 0.85. This may result in clinicians to inadvertently revascularize patients with FFR measurements >0.80.

Transcatheter Treatment of Pure Aortic Regurgitation in a Horizontal Aorta Complicated by Valve Embolization and Aortic Dissection.

A 83-year-old female with severe aortic regurgitation (AR) and an horizontal ascending aorta was scheduled for a transcatheter aortic valve replacement. After the complete deployment, a Portico 29 mm valve embolized in the ascending aorta due to the unfavorable anatomy of the anchoring zone. A second Portico 29 mm was successfully implanted using the embolized valve for superior anchoring. The patient died 7 days after the procedure due to a retrograde aortic dissection. This case shows a rare but possible complication that occurs especially in unfavorable and complex aortic anatomies.

Predictors of Advanced Conduction Disturbances Requiring a Late (≥48 H) Permanent Pacemaker Following Transcatheter Aortic Valve Replacement.

OBJECTIVES: This study sought to determine predictors of advanced conduction disturbances requiring late (≥48 h) permanent pacemaker replacement (PPM) after transcatheter aortic valve replacement (TAVR). METHODS: Data of consecutive patients were identified by retrospective review of a TAVR database of a single center in Milan, Italy, between October 2007 and July 2015. We defined delta PR (ΔPR) and delta QRS (ΔQRS) interval as the difference between the last PR and QRS length available 48 h after TAVR and the baseline PR and QRS length. RESULTS: Overall population included 740 patients. We excluded 78 patients who already had a PPM and 51 patients who received a PPM <48 h after TAVR. The final analysis included 611 patients. Fifty-four patients (8.8%) developed an advanced conduction disturbance requiring PPM ≥48 h following TAVR. Patients who required a late PPM implant had a wider QRS width (113 ± 25 ms vs. 105 ± 23 ms; p = 0.009) and a higher prevalence of baseline right bundle branch block (12.9% vs. 5.3%; p = 0.026) and were more likely to have a self-expandable valve implanted (51.8% vs. 31.9%; p = 0.003). The ΔPR was 40 ± 51 ms (p = 0.0001) and the ΔQRS was 22 ± 61 ms (p = 0.001). Multivariable analysis revealed that baseline right bundle branch block (odds ratio: 3.56; 95% confidence interval: 1.07 to 11.77; p = 0.037) and ΔPR (odds ratio for each 10-ms increase: 1.31; 95% confidence interval: 1.18 to 1.45; p = 0.0001) are independent predictors of delayed advanced conduction disturbances. CONCLUSIONS: This analysis showed that baseline right bundle branch block and the amount of increase of PR length after TAVR are independent predictors of late (≥48 h) advanced conduction disturbances requiring PPM replacement after TAVR in this cohort. A simple ECG analysis could help in detecting potentially lethal advanced conduction disturbances that could occur more than 48 h after TAVR.

TAVI and Post Procedural Cardiac Conduction Abnormalities.

Transcatheter aortic valve implantation (TAVI) is a worldwide accepted alternative for treating patients at intermediate or high risk for surgery. In recent years, the rate of complications has markedly decreased except for new-onset atrioventricular and intraventricular conduction block that remains the most common complication after TAVI. Although procedural, clinical, and electrocardiographic predisposing factors have been identified as predictors of conduction disturbances, new strategies are needed to avoid such complications, particularly in the current TAVI era that is moving quickly toward the percutaneous treatment of low-risk patients. In this article, we will review the incidence, predictive factors, and clinical implications of conduction disturbances after TAVI.

Percutaneous Direct Annuloplasty With Edge-to-Edge Technique for Mitral Regurgitation: Replicating a Complete Surgical Mitral Repair in a One-Step Procedure.

Surgical treatment of functional mitral regurgitation (MR) is usually based on the correction of both annular dilation and leaflet disease to minimize the risk of recurrence of MR at follow-up. This combined approach may also represent an interesting strategy during transcatheter mitral valve repair systems. We report a successful case of combined Cardioband (Edwards Lifesciences, Irvine, California) and MitraClip (Abbott, Santa Clara, California) implantation for the treatment of functional MR, with good acute and medium-term clinical and echocardiographic outcomes.

The future of percutaneous tricuspid valve interventions.

Tricuspid valve regurgitation has a high prevalence and, when severe, is associated with poor outcomes. Nevertheless, surgical repair or replacement (isolated or as a part of a combined procedure) is rarely performed due to high surgical risk. Therefore, there is a significant unmet clinical need for percutaneous transcatheter-based treatments. Significant development in percutaneous therapies for both aortic and mitral valve disease has been accomplished over the last two decades, while transcatheter therapies for the tricuspid valve are still at an early stage. We are today at a cross-road of new transcatheter devices that are becoming available for the treatment of tricuspid regurgitation; the current review evaluates the challenges that current and future technologies have to face in order to become a safer, less invasive and equally effective alternative to surgery.

Cerebral Embolic Risk During Transcatheter Mitral Valve Interventions: An Unaddressed and Unmet Clinical Need?

As new transcatheter mitral valve (MV) interventions continuously evolve, potential procedure-related adverse events demand careful investigation. The risk of cerebral embolic damage is ubiquitous in any left-sided structural heart intervention (and potentially linked to long-term neurocognitive sequelae); therefore, efforts to evaluate these aspects in the field of catheter-based MV procedures are justified. Given the peculiarities of MV anatomy, MV disease, and MV procedures, the lessons learned from other transcatheter heart interventions (i.e., transcatheter aortic valve replacement) cannot be directly translated to MV applications. Through a systematic assessment of available evidence, the authors present and discuss procedure- and patient-related factors potentially associated with cerebral embolic risk during catheter-based MV interventions. Given the paucity of available data in this field, future large, dedicated studies are needed to understand whether cerebral embolic injury represents a real clinical issue during MV procedures.