30-Day Outcomes With the Portico Transcatheter Heart Valve: Insights From a Multi-Centre Australian Observational Study.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an established therapy for the treatment of aortic valve disease in appropriately selected patients. Previous studies using the self-expanding Portico transcatheter heart valve (THV), (Abbott Structural Heart, St Paul, MN, USA) have demonstrated the technical feasibility of this system albeit in the hands of relatively inexperienced Portico users. The objective of this study was to assess the real-world safety and efficacy of the Portico THV (with and without the FlexNav delivery system, Abbott Structural Heart) at the 30-day timepoint in an Australian cohort. METHODS AND RESULTS: This study was a retrospective real-world cohort analysis of 269 consecutive patients with severe aortic valve disease who underwent TAVI at multiple centres within Australia between February 2015 and April 2021. Of the 269 patients, 51.7% were female, mean Society of Thoracic Surgeons (STS) score was 5.2 (±6.8) and 98.5% had successful implantations. Thirty (30)-day post-implantation all-cause mortality was observed in one (0.4%) patient, major vascular complications in two (0.7%) patients, more-than-mild paravalvular leak in six (2.2%) patients and requirement for new permanent pacemaker implantation in 27 (10.2%) patients. Haemodynamic parameters at 30 days included mean effective orifice area (EOA) of 2.3 (±0.9) cm2 and mean aortic valve gradient (AVG) of 9.6 (±6.2) mmHg. CONCLUSION: This analysis of the Portico THV in a real-world setting suggested that the system is associated with satisfactory safety and efficacy parameters. Previously published datasets may not have found similar findings owing to lower operator experience with the Portico THV system.

The Extent of Aortic Atherosclerosis Predicts the Occurrence, Severity, and Recovery of Acute Kidney Injury After Transcatheter Aortic Valve Replacement.

BACKGROUND: Acute kidney injury (AKI) can be a major complication of transcatheter aortic valve replacement (TAVR). Atheroembolization of debris during catheter manipulation has been considered as a potential factor causing AKI. This study investigates the impact of aortic atheroma burden on AKI post-TAVR and evaluates the potential of preoperative multislice computed tomographic (MSCT) imaging for the assessment of AKI in these patients. METHODS AND RESULTS: Preoperative multislice computed tomographic images were analyzed in 278 patients with symptomatic severe aortic stenosis who underwent TAVR. AKI was defined as an absolute increase in serum creatinine ≥0.3 mg/dL. Aorta vessel and lumen areas in each 1-mm cross-sectional image were measured. Percent atheroma volume above (PAVabove renal arteries) and below (PAVbelow renal arteries) renal arteries were calculated by the following formula: PAV={Σ (vessel area-lumen area)/Σ(vessel area)}×100. AKI occurred in 92 patients (33.1%) after TAVR. AKI was associated with a greater PAV above (30.4±8.2 versus 21.3±5.8%; P=0.02) but not below (28.9±7.7 versus 25.8±6.1%; P=0.41) the renal arteries. Greater PAVabove renal arteries was associated directly with AKI severity ( P=0.008) and inversely with recovery in serum creatinine level from peak to discharge ( r=0.78; P=0.002). Multivariate analysis demonstrated that PAVabove renal arteries was a significant predictor of AKI ( P=0.02). Receiver-operating curve analysis identified PAVabove renal arteries >29.5% as an optimal threshold to predict AKI. CONCLUSIONS: Suprarenal aortic atheroma burden is associated with the occurrence, severity, and recovery of AKI after TAVR. This highlights the utility of preoperative assessment of aortic atherosclerosis on multislice computed tomography to identify patients at high-risk for AKI.

Transcatheter aortic valve implantation: a new standard of care.

Aortic stenosis is the most common valvular lesion requiring intervention and with an ageing population, its burden is likely to increase. Increasing comorbidity and a desire for less invasive treatment strategies has facilitated the expansion of percutaneous aortic valve therapies. Robust clinical trial data are now available to support the role of transcatheter aortic valve implantation (TAVI) in patients of prohibitive, high and now intermediate surgical risk. The introduction of a Medicare Benefits Schedule reimbursement is likely to see TAVI use grow exponentially in Australia over the next 5 years. Clinical trials evaluating low risk patients may be the final frontier to see TAVI become the standard of care for most patients with severe aortic stenosis.

Safety and performance of the second generation EnligHTN™ Renal Denervation System in patients with drug-resistant, uncontrolled hypertension.

BACKGROUND AND AIMS: Catheter-based renal denervation for the treatment of drug-resistant hypertension has been intensively investigated in recent years. To date, only limited data have been published using multi-electrode radiofrequency ablation systems that can deliver lesions with a pre-determined pattern. This study was designed to evaluate the safety and performance of the second generation EnligHTN™ Renal Denervation System. METHODS: This first-in-human, prospective, multi-center, non-randomized study included 39 patients (62% male, mean age 63 years, and mean baseline office blood pressure 174/93 mmHg) with drug-resistant hypertension. The primary safety and performance objectives were to characterize, from baseline to 6 months post procedure, the rate of serious procedural and device related adverse events, as adjudicated by an independent Clinical Events Committee, and the reduction of office systolic blood pressure. RESULTS: Renal artery denervation, using the second generation EnligHTN multi-electrode system significantly reduced office blood pressure from baseline to 1, 3, 6, 12, 18 and 24 months by 19/7, 26/9, 25/7, 23/7, 25/8 and 27/9 mmHg, respectively (p ≤ 0.0005). No serious device or procedure related adverse events affecting the renal arteries or renal function occurred through 24 months of follow-up. CONCLUSIONS: Renal sympathetic denervation using the second generation EnligHTN Renal Denervation System resulted in safe, rapid, and significant mean office blood pressure reduction that was sustained through 24 months. Future studies will need to address the utility of this system against an appropriate sham based comparator.

Aortic atheroma burden predicts acute cerebrovascular events after transcatheter aortic valve implantation: insights from volumetric multislice computed tomography analysis.

AIMS: Embolisation of atheromatous debris during catheter manipulation is considered to underlie acute cerebrovascular events (CVE) after transcatheter aortic valve implantation (TAVI). However, the relationship between aorta atheroma burden and acute CVE after TAVI has not been established. We investigated the impact of aorta atheroma burden on acute CVE. METHODS AND RESULTS: Preoperative multislice computed tomographic (MSCT) images in 278 patients receiving TAVI were analysed. Total atheroma volume (TAV) was calculated by measuring aorta vessel and lumen areas in every 1 mm cross-sectional image. Acute CVE was observed in 16 patients. Patients having acute CVE were more likely to have a prior CVE (p=0.002), and to exhibit greater TAV in the ascending aorta (12.8±3.5 vs. 7.0±2.1 cm3, p<0.001) and the aortic arch (3.1±1.6 vs. 1.2±0.2 cm3, p<0.001). TAV in the ascending aorta >10.3 cm3 and in the aortic arch >2.9 cm3 predicted acute CVE. The incidence of acute CVE was highest (36.4%) if patients had a prior CVE and TAV in the ascending aorta and the aortic arch above cut-offs. CONCLUSIONS: Patients with acute CVE after TAVI had greater aorta atheroma burden. Our findings might underscore preoperative MSCT analysis of aorta atherosclerosis to identify high-risk patients for acute CVE, who might require an embolic protection device during TAVI.

Transcatheter Aortic Valve Replacement: A Solution for the Young, Inoperable and Regurgitant.

Transcatheter aortic valve replacement (TAVR) has become an established treatment for patients with severe aortic stenosis and high surgical risk. Ten years of technological advances in valve structure and delivery systems alongside growing operator and centre experience has opened TAVR implantation to an increasingly broad range of patients. The extension to off-label use however needs careful consideration and monitoring. Through discussion of our case involving an inoperable 24-year-old male with severe aortic regurgitation (AR), we highlight the need for an experienced and multidisciplinary team, together with early and extensive patient and family disclosure and engagement, prior to considering any off-label application of TAVR.

Transfemoral aortic valve replacement with the repositionable Lotus Valve System in high surgical risk patients: the REPRISE I study.

AIMS: To assess outcomes with a new fully repositionable and retrievable valve for transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: The Lotus Aortic Valve System is designed to facilitate precise positioning and minimise paravalvular regurgitation. REPRISE I enrolled symptomatic, high-surgical-risk patients with severe aortic stenosis. The primary endpoint (clinical procedural success) included successful implantation without major adverse cardiovascular or cerebrovascular events (MACCE). In all patients (N=11) the first Lotus Valve was successfully deployed. Partial resheathing to facilitate accurate placement was attempted and successfully performed in four patients; none required full retrieval. The primary endpoint was achieved in 9/11 with no in-hospital MACCE in 10/11. There was one major stroke; in another patient, discharge mean aortic gradient was 22 mmHg (above the primary endpoint threshold of 20 mmHg), but improved to 15 mmHg at 30 days. The cohort's mean aortic gradient decreased from 53.9±20.9 mmHg at baseline to 15.4±4.6 mmHg (p<0.001) at one year; valve area increased from 0.7±0.2 cm2 to 1.5±0.2 cm2 (p<0.001). Discharge paravalvular aortic regurgitation, adjudicated by an independent core laboratory, was mild (n=2), trivial (n=1), or absent (n=8). Four patients required a permanent pacemaker post-procedure. There were no deaths, myocardial infarctions or new strokes through one year. CONCLUSIONS: Initial results support proof-of-concept with the Lotus Valve for TAVR.