Predictors and Trends of New Permanent Pacemaker Implantation: A Subanalysis of the International Navitor IDE Study.

Background: The Navitor Investigational Device Exemption (IDE) study is a prospective, multicenter, global study assessing the safety and effectiveness of the Navitor valve in a population with severe, symptomatic aortic stenosis who are at high and extreme surgical risk. The impact of pre-existing conduction abnormalities and implantation technique on new permanent pacemaker implantation (PPI) for the Navitor platform is not fully understood. Therefore, the goal of this analysis was to investigate the associations between patient and procedural factors and the 30-day new PPI rate. Methods: A total of 260 patients who underwent implantation of a Navitor valve in the Navitor IDE study were reviewed. Patients with preprocedural permanent pacemakers (n = 28) were excluded. Baseline risk factors were assessed for statistical significance. Multivariable logistic regression analyses were performed to identify independent predictors of new PPI. Results: Mean age of the pacemaker-naïve population was 83.3 ± 5.2 years, 58.6% were female, average Society of Thoracic Surgeons score was 3.8% ± 1.9%, median frailty score was 1 (interquartile range 1, 2), and 17.7% were deemed at extreme surgical risk. Pre-existing first-degree atrioventricular block and right bundle branch block significantly increased the risk of new PPI postimplantation, whereas left bundle branch block did not. Membranous septum length in relation to noncoronary cusp implant depth was a significant predictor of new PPI, with higher rates of new PPI observed when noncoronary cusp implant depth exceeded membranous septum length. Analysis of implant depth alone revealed deeper implants were associated with a higher rate of new PPI, regardless of patient baseline conduction abnormality. Conclusions: The 30-day rate of new PPI in the Navitor IDE study is associated with patient pre-existing baseline conduction disturbances and implantation depth.

Feasibility and Utility of Anatomical and Physiological Evaluation of Coronary Disease With Cardiac CT in Severe Aortic Stenosis (FUTURE-AS Registry): Rationale and Design.

Background: Coronary artery disease (CAD) in patients with severe aortic stenosis (AS) is common and may be associated with worse outcomes. Computed tomography coronary angiography (CTCA) and fractional flow reserve derived from computed tomography (FFRCT) are tools for comprehensive coronary assessment. The utility and safety of CTCA and FFRCT in the work-up for transcatheter aortic valve replacement (TAVR) is not established, especially in an evolving landscape that involves younger TAVR patients. The FUTURE-AS Registry will assess the utility and safety of cardiac-optimized CTCA and FFRCT to evaluate CAD and guide referral for downstream invasive coronary angiography (ICA) in patients with severe AS being considered for TAVR. Methods: FUTURE-AS is an international, prospective, multicenter registry of patients with severe AS referred for TAVR being assessed for CAD with CTCA and FFRCT. The primary end point is the per-patient sensitivity and negative predictive value of CTCA and FFRCT for identifying anatomical and physiologically significant CAD compared to ICA and invasive FFR. The safety end point is the incidence of symptomatic hypotension or bradycardia requiring intervention following the administration of nitroglycerin or ß-blocker medications. Feasibility end points include the incidence of noninterpretable CTCA scans and CTCA scans not adequate for FFR analysis. Other utility end points include specificity, positive predictive value, and accuracy of CTCA and FFRCT. Lastly, the potential of a CTCA and FFRCT guided strategy to defer pre-TAVR ICA will be assessed. Conclusions: FUTURE-AS will characterize the utility, safety, and feasibility of CTCA and FFRCT for coronary assessment pre-TAVR.

Aortic valve laceration following rotational atherectomy: a case report.

Background: Iatrogenic aortic valve injury during cardiovascular catheterization interventions is extremely rare. Severe aortic regurgitation that ensues can be catastrophic and the management is typically with surgical valve replacement or repair. Percutaneous management of native pure aortic regurgitation is difficult due to anatomical challenges and the limitations of current transcatheter heart valve technology to anchor in the absence of leaflet or annular calcification. Case Summary: An 82-year-old female underwent rotational atherectomy (RA) for a severely calcified stenosis of the left anterior descending artery. The patient was discharged well following placement of two drug eluting stents. She represented to hospital 7 days later with acute pulmonary oedema. Bedside transthoracic echocardiography demonstrated new, severe AR with preserved left ventricular size and function. Review of the prior percutaneous coronary intervention revealed significant trauma to the aortic valve during RA, with contrast seen refluxing into the LV during diastole, evolving throughout the procedure. Given the patient was not an operative candidate, an oversized transcatheter aortic valve was successfully implanted. In the post-operative setting, the patient suffered a stroke. Extensive hypoattenuated leaflet thickening (HALT) and thrombus was seen on dedicated 4D CT imaging. She made full neurological recovery and valve function returned to normal following a period of anticoagulation. Conclusion: Although iatrogenic aortic valve laceration is rare, this case highlights several important learning points including the importance of good guide catheter support during RA; the feasibility of Transcatheter Aortic Valve Replacement for pure native AR; and the detection and management of HALT.

Hybrid Transcatheter Approach to an Iatrogenic Left Ventricle-Coronary Sinus Fistula.

This clinical case describes a subacute presentation of decompensated heart failure secondary to an iatrogenic left ventricle-to-coronary sinus fistula after sequential mitral valve surgical procedures. Computed tomography was used to select an unconventional hybrid transapical access approach and facilitate successful closure using a vascular plug.

Thirty-day and one-year outcomes of the Navitor transcatheter heart valve in patients with aortic stenosis: the prospective, multicentre, global PORTICO NG Study.

BACKGROUND: The Navitor transcatheter heart valve (THV) is a self-expanding valve, with an intra-annular leaflet position and an outer cuff intended to reduce paravalvular leak (PVL). AIMS: The aim of the PORTICO NG Study is to assess the safety and performance of the Navitor THV in patients with symptomatic, severe aortic stenosis who are at high or extreme surgical risk. METHODS: PORTICO NG is a prospective, multicentre, global, single-arm, investigational study with follow-up at 30 days, 1 year, and annually up to 5 years. The primary endpoints are all-cause mortality and moderate or greater PVL at 30 days. Valve Academic Research Consortium-2 events and valve performance are assessed by an independent clinical events committee and echocardiographic core laboratory. RESULTS: A total of 120 high- or extreme-risk subjects (age 83.5±5.4 years; 58.3% female; Society of Thoracic Surgeons score 4.0±2.0%) were enrolled in the European conformity (CE) mark cohort. Procedural success was high at 97.5%. At 30 days, the rate of all-cause mortality was 0%, and no subjects had moderate or greater PVL. The rate of disabling stroke was 0.8%, life-threatening bleeding was 2.5%, stage 3 acute kidney injury 0%, major vascular complications 0.8%, and new pacemaker implantation 15.0%. At 1 year, the rates of all-cause mortality and disabling stroke were 4.2% and 0.8%, respectively. The rate of moderate PVL was 1.0% at 1 year. Haemodynamic performance with a mean gradient of 7.5±3.2 mmHg and effective orifice area of 1.9±0.4 cm2 was sustained up to 1 year. CONCLUSIONS: The PORTICO NG Study demonstrates low rates of adverse events and PVL up to 1 year in patients at high or extreme surgical risk, confirming the safety and efficacy of the Navitor THV system.

30-Day Clinical Outcomes of a Self-Expanding Transcatheter Aortic Valve: The International PORTICO NG Study.

BACKGROUND: The self-expanding, intra-annular Navitor (Abbott Structural Heart) valve includes an outer cuff to reduce paravalvular leak (PVL) and large stent cells for future coronary access. OBJECTIVES: The purpose of the PORTICO NG (Evaluation of the Portico NG [Next Generation] Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis) study is to evaluate the safety and effectiveness of the Navitor valve in patients with symptomatic, severe aortic stenosis who are at high or extreme surgical risk. METHODS: PORTICO NG is a prospective, multicenter, global study with follow-up at 30 days, 1 year, and annually through 5 years. The primary endpoints are all-cause mortality and moderate or greater PVL at 30 days. Valve Academic Research Consortium-2 events and valve performance are assessed by an independent clinical events committee and echocardiographic core laboratory. RESULTS: A total of 260 subjects were treated at 26 clinical sites across Europe, Australia, and the United States between September 2019 and August 2022. The mean age was 83.4 ± 5.4 years, 57.3% were female, and the average Society of Thoracic Surgeons score was 3.9% ± 2.1%. At 30 days, the rate of all-cause mortality was 1.9%, and no subjects had moderate or greater PVL. The rate of disabling stroke was 1.9%, life-threatening bleeding was 3.8%, stage 3 acute kidney injury was 0.8%, major vascular complications were 4.2%, and new permanent pacemaker implantation was 19.0%. Hemodynamic performance included a mean gradient of 7.4 ± 3.5 mm Hg and an effective orifice area of 2.00 ± 0.47 cm2. CONCLUSIONS: The Navitor valve is safe and effective for the treatment of subjects with severe aortic stenosis who are at high or greater risk for surgery, which is supported by low rates of adverse events and PVL. (Evaluation of the Portico NG [Next Generation] Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis [PORTICO NG]; NCT04011722).

One-Year Results of the Portico Transcatheter Aortic Heart Valve Using the Next-Generation FlexNav Delivery System.

Background: The FlexNav delivery system (DS) features a hydrophilic coating, stability layer, and integrated sheath to facilitate valve deployment in vessel diameters ≥5.0 mm. Methods: Data were pooled from 2 concurrent prospective, multicenter, premarket studies (PORTICO IDE [n = 147] and FlexNav EU CE Mark [n = 46]) to evaluate the safety and efficacy of the FlexNav DS to deliver the Portico valve in the Global FlexNav study. The primary end point was Valve Academic Research Consortium (VARC)-2 major vascular complication rate at 30 days. These outcomes were compared with those of the commercially available valve arm from the PORTICO IDE study. Results: The Global FlexNav study enrolled 193 high- or extreme-risk subjects for sugery. The mean age was 84.8 years, and 59.6% were women, with a mean Society of Thoracic Surgeons score of 5.2%. At 1 year, the rate of all-cause mortality was 5.2%, disabling stroke 2.1%, and mild or less paravalvular leak 99.4%. The mean aortic gradient was maintained at 7.4 ± 4.3 mm Hg through 1 year. At 1 year, 96.8% of subjects were classified as New York Heart Association class I or II. A pacemaker was implanted in 15.4% of subjects at 30 days and 18.4% at 1 year. The results of the Portico valve in the Global FlexNav study are comparable with the results from the commercially available valve arm in the PORTICO IDE study. Conclusion: The FlexNav DS was shown to be safe for the delivery of the Portico valve, which demonstrated sustained treatment benefits at 1 year with low rates of all-cause mortality or disabling stroke, improved heart failure symptoms, and excellent valve performance.

Early Australian experience with intravascular lithotripsy treatment of severe calcific coronary stenosis: IVL in acute/chronic coronary syndromes.

Aims: Calcified coronary stenoses are a serious impediment to optimal stent expansion and can lead to stent failure and catastrophic adverse outcomes. We hereby present early Australian experience with intravascular lithotripsy for the treatment of calcific lesions in acute and chronic coronary syndromes. Methods and results: This was a single-centre retrospective study of all patients treated with intravascular lithotripsy (IVL) between October 2019 and June 2021. Patient demographics, procedural variables, and treatment safety/efficacy outcomes were evaluated. During this period, there were 40 patients and 41 coronary lesions with IVL-assisted percutaneous coronary intervention (PCI) (70% male; mean age 72.8±9.5 years). Indications for PCI were acute coronary syndromes in 25 patients (62.5%), and stable angina in 15 patients (37.5%). Upfront IVL usage occurred in 5% of cases with the rest being bailout procedures due to suboptimal initial balloon predilatation or stent underexpansion. Angiographic success (<20% residual stenosis) occurred in 37 cases (92.5%), with mean residual stenosis of 8.25%±8.5%. Two patients experienced procedural complications (5%). Conclusions: IVL appears to be a safe and effective modality in modifying coronary calcium to achieve optimal stent expansion in real-world practice. This device obviates the need for more complex lesion preparation strategies such as rotational or orbital atherectomy.

Long-Term Echocardiographic Follow-Up After Transcatheter Aortic Valve Implantation to Assess Structural Valve Deterioration and Bioprosthetic Valve Failure.

BACKGROUND: Indications for transcatheter aortic valve implantation (TAVI) in aortic stenosis are expanding and the life expectancy of patients following TAVI is increasing. Determining the long-term durability of TAVI valves is therefore important. Rates of long-term (≥5 years) structural valve deterioration (SVD) vary widely and there are currently no comparable data from Australia. The aim herein was to determine the incidence of haemodynamic SVD and bioprosthetic valve failure (BVF) using recently standardised definitions in a Western Australian cohort after at least 5 years. METHODS: This is a retrospective cohort study of consecutive patients undergoing TAVI at Royal Perth Hospital between January 2009 and January 2015. Of 211 patients, 55 survived ≥5 years and had echocardiographic data available for review. Median time to the echocardiogram was 5.9 years (max 7.8 years); 49% male, mean age 83 years. RESULTS: Of the 55 survivors who had echocardiograms available ≥5 years after TAVI, four (9%) had moderate haemodynamic SVD and one (2%) had severe SVD and BVF. CONCLUSIONS: Our results suggest excellent long-term durability of contemporary TAVI valves in an Australian cohort with very low incidence of SVD and BVF. These findings add confidence to the expanding applications of TAVI valves.

Mitral valve-in-valve implantation during pregnancy.

A 32-year-old, 11-week pregnant African woman with known rheumatic heart disease presented to the emergency department with worsening shortness of breath on exertion. She had undergone a double bioprosthetic valve replacement and left atrial appendage resection 8 years prior for severe mitral stenosis, moderate mitral regurgitation and moderate aortic regurgitation. A transo-oesophageal echocardiography at this presentation confirmed a morphologically calcified and stenosed mitral bioprosthesis, with moderate stenosis of her aortic bioprosthesis. Her multidisciplinary team, including cardiologists, cardiothoracic surgeons and obstetricians, came to a consensus decision to proceed with a transseptal transcatheter valve implantation within the mitral valve prosthesis (valve-in-valve implantation). Transthoracic echocardiography performed 2 months post procedure showed satisfactory mitral valve gradients and at 30 weeks' gestation, she successfully delivered her fifth child. 2 years later, the valve in valve complex is still functioning well.

A unique case report of mitral valve endocarditis associated with coronary stent infection.

BACKGROUND: Despite increasing use of percutaneous coronary intervention and stenting, septic complications such as coronary stent infections are rare. We report a unique case of mitral valve infective endocarditis and associated coronary stent infection which emerged 6 months after index stent insertion. CASE SUMMARY: A 56-year-old previously healthy man underwent percutaneous coronary intervention and stenting of left circumflex (LCx) coronary artery in the setting of non-ST-segment elevation myocardial infarction. Six months later, he represented with inferior ST-segment elevation myocardial infarction and was found to have a coronary pseudoaneurysm of stented segment of LCx. The pseudoaneurysm was treated with insertion of a covered stent, and immediately following that he developed sepsis with methicillin-sensitive Staphylococcus aureus bacteraemia. Comprehensive work-up resulted in the diagnosis of mitral valve endocarditis complicated by coronary stent infection and myocardial abscess formation. He was managed with initial prolonged systemic antibiotic treatment followed by mitral valve replacement. Post-operative course was uneventful with a short duration of oral antibiotics. At 6-year follow-up, the patient was well with the satisfactory echocardiographic result. DISCUSSION: This is a very rare case of mitral valve endocarditis with extensive cardiac involvement including coronary stent infection and surrounding myocardial abscess. Stents can act as an ideal vector for bacterial adherence from which bacteria could spread to the arterial wall and adjacent myocardium. This case suggests a potential complication of delayed endothelialization and risk of infective complication due to bacterial seeding or embolization.

Safety Profile of an Intra-Annular Self-Expanding Transcatheter Aortic Valve and Next-Generation Low-Profile Delivery System.

OBJECTIVES: The aim of this study was to characterize the safety profile of an intra-annular self-expanding valve with a next-generation low-profile delivery system (DS). BACKGROUND: Key design modifications to the FlexNav DS include the addition of a hydrophilic-coated, integrated sheath and stability layer to facilitate gradual, controlled deployment in vessels with diameter ≥5 mm. METHODS: Patients were pooled from 2 concurrent prospective, multicenter, single-arm studies (FlexNav DS arm of PORTICO IDE [Portico Re-Sheathable Transcatheter Aortic Valve System U.S. IDE Trial] [n = 134] and the FlexNav EU CE Mark Study [n = 46]) for the analysis. The primary endpoint was Valve Academic Research Consortium-2-defined major vascular complications at 30 days. Clinical outcomes and valve performance were assessed through 30 days by an independent clinical events committee and an echocardiography core laboratory, respectively. RESULTS: One hundred forty high-risk and 40 extreme-risk subjects enrolled between October 15, 2018, and December 10, 2019, from 28 sites in the United States, Australia, and Europe who underwent attempted transfemoral Portico valve implantation were included. The mean age was 85.1 ± 5.6 years, 60% were women, the mean Society of Thoracic Surgeons score was 5.3%, and 96.1% presented with ≥1 frailty factor. Technical device success was 96.7%. At 30 days, the rate of major vascular complications was 5.0%, with 4.4% of complications adjudicated as access site-related (3.3% transcatheter aortic valve replacement DS access site-related). Death (0.6%) and disabling stroke (1.1%) were rare. The rate of new permanent pacemaker implantation was 15.4%. Echocardiography revealed a mean gradient of 7.1 ± 3.2 mm Hg, mean valve area of 1.77 ± 0.41 cm2, and a 4.1% rate of moderate paravalvular leak at 30 days. CONCLUSIONS: Portico valve implantation with the FlexNav DS was associated with an excellent safety profile at 30 days.

Performance and Safety of Transfemoral TAVI With SAPIEN XT in Australian Patients With Severe Aortic Stenosis at Intermediate Surgical Risk: SOLACE-AU Trial.

BACKGROUND: To determine the safety and performance of the SAPIEN XT transcatheter heart valve (THV) in Australian patients with severe aortic stenosis (AS) and intermediate surgical risk. METHODS: Eligible patients in this multi-centre, prospective, consecutively enrolled, non-randomised, clinical trial, received transcatheter aortic valve replacement via femoral artery access. Follow-up visits were at discharge, 30 days, and 6, 12, and 24 months. The primary endpoint was Valve Academic Research Consortium-2 composite safety at 30 days: all-cause mortality, all stroke, life-threatening bleeding, acute kidney injury-Stage 3, coronary artery obstruction requiring intervention, major vascular complication, and valve-related dysfunction requiring repeat procedure. Other endpoints were device success (successful vascular access, delivery, and deployment; correct position; intended performance mean aortic valve gradient <20 mmHg, mild or less paravalvular aortic regurgitation [PAR]; and only one valve implanted) and New York Heart Association functional class (NYHA). Kaplan-Meier (KM) estimates were calculated for the primary endpoint. RESULTS: At baseline, mean patient (N=199) age was 85.5 years, mean Society of Thoracic Surgeon score was 5.9, and 78.4% were in NYHA class III/IV. The primary composite endpoint KM estimate was 12.1%. Device success was 88.8%. SAPIEN XT was implanted in the proper location in 98.5% (n=2: valve-in-valve procedures, n=1: no implant due to left main coronary artery occlusion). No device malfunctions were reported. The post procedure PAR was mild or less in 93.8% of patients. Mean aortic gradient decreased from baseline (50.0 mmHg) to 2 years (10.3 mmHg). Most patients (90.9%) were in NYHA class I/II at 30 days. New permanent pacemaker rate was 8.1%. Stroke at 30 days was 3.5% (1.5% disabling). CONCLUSION: SAPIEN XT was safe and improved heart failure symptoms and valve haemodynamics in this cohort of Australian patients.

Self-expanding intra-annular versus commercially available transcatheter heart valves in high and extreme risk patients with severe aortic stenosis (PORTICO IDE): a randomised, controlled, non-inferiority trial.

BACKGROUND: Randomised trial data assessing the safety and efficacy of the self-expanding intra-annular Portico transcatheter aortic valve system (Abbott Structural Heart, St Paul, MN, USA) compared with any commercially available valves are needed to compare performance among designs. METHODS: In this prospective, multicentre, non-inferiority, randomised controlled trial (the Portico Re-sheathable Transcatheter Aortic Valve System US Investigational Device Exemption trial [PORTICO IDE]), high and extreme risk patients with severe symptomatic aortic stenosis were recruited from 52 medical centres experienced in performing transcatheter aortic valve replacement in the USA and Australia. Patients were eligible if they were aged 21 years or older, in New York Heart Association functional class II or higher, and had severe native aortic stenosis. Eligible patients were randomly assigned (1:1) using permuted block randomisation (block sizes of 2 and 4) and stratified by clinical investigational site, surgical risk cohort, and vascular access method, to transcatheter aortic valve replacement with the first generation Portico valve and delivery system or a commercially available valve (either an intra-annular balloon-expandable Edwards-SAPIEN, SAPIEN XT, or SAPIEN 3 valve [Edwards LifeSciences, Irvine, CA, USA]; or a supra-annular self-expanding CoreValve, Evolut-R, or Evolut-PRO valve [Medtronic, Minneapolis, MN, USA]). Investigational site staff, implanting physician, and study participant were unmasked to treatment assignment. Core laboratories and clinical event assessors were masked to treatment allocation. The primary safety endpoint was a composite of all-cause mortality, disabling stroke, life-threatening bleeding requiring transfusion, acute kidney injury requiring dialysis, or major vascular complication at 30 days. The primary efficacy endpoint was all-cause mortality or disabling stroke at 1 year. Clinical outcomes and valve performance were assessed up to 2 years after the procedure. Primary analyses were by intention to treat and the Kaplan-Meier method to estimate event rates. The non-inferiority margin was 8·5% for primary safety and 8·0% for primary efficacy endpoints. This study is registered with ClinicalTrials.gov, NCT02000115, and is ongoing. FINDINGS: Between May 30 and Sept 12, 2014, and between Aug 21, 2015, and Oct 10, 2017, with recruitment paused for 11 months by the funder, we recruited 1034 patients, of whom 750 were eligible and randomly assigned to the Portico valve group (n=381) or commercially available valve group (n=369). Mean age was 83 years (SD 7) and 395 (52·7%) patients were female. For the primary safety endpoint at 30 days, the event rate was higher in the Portico valve group than in the commercial valve group (52 [13·8%] vs 35 [9·6%]; absolute difference 4·2, 95% CI -0·4 to 8·8 [upper confidence bound {UCB} 8·1%]; pnon-inferiority=0·034, psuperiority=0·071). At 1 year, the rates of the primary efficacy endpoint were similar between the groups (55 [14·8%] in the Portico group vs 48 [13·4%] in the commercial valve group; difference 1·5%, 95% CI -3·6 to 6·5 [UCB 5·7%]; pnon-inferiority=0·0058, psuperiority=0·50). At 2 years, rates of death (80 [22·3%] vs 70 [20·2%]; p=0·40) or disabling stroke (10 [3·1%] vs 16 [5·0%]; p=0·23) were similar between groups. INTERPRETATION: The Portico valve was associated with similar rates of death or disabling stroke at 2 years compared with commercial valves, but was associated with higher rates of the primary composite safety endpoint including death at 30 days. The first-generation Portico valve and delivery system did not offer advantages over other commercially available valves. FUNDING: Abbott.