Long-Term Outcomes of Contemporary Percutaneous Coronary Intervention with the Xience Drug-Eluting Stent: Results from a Multicentre Australian Registry.

Introduction: Several large registries have evaluated outcomes after percutaneous coronary intervention (PCI) in the USA, however there are no contemporary data regarding long-term outcomes after PCI, particularly comparing new generation drug-eluting stents (DES) with other stents in Australia. Additionally, approval of new-generation drug-eluting stents (DES) is almost exclusively based on non-inferiority trials comparing outcomes with early generation DES, and there are limited data comparing safety and efficacy outcomes of new-generation DES with bare metal stents (BMS). This study reports in-hospital and long-term outcomes after PCI with the Xience DES from a large national registry, the GenesisCare Outcomes Registry (GCOR). Methods: The first 1500 patients consecutively enrolled from January 2015 to January 2019 and treated exclusively with either Xience DES or BMS and eligible for 1-year follow-up were included. Baseline patient and procedural data, major adverse cardiovascular events (MACE) in-hospital, at 30 days and 1-year, and medications were reported and analysed with respect to Xience DES (n = 1000) or BMS (n = 500) use. Results: In this cohort the mean age was 68.4 ± 10.7 years, 76.9% were male, 24.6% had diabetes mellitus and 45.9% presented with acute coronary syndromes. Of the overall cohort of 4765 patients from this period including all DES types, and patients who received multiple DES or a combination of DES and BMS, DES were exclusively used in 3621 (76.0%) patients, and BMS were exclusively used in 596 (12.5%). In comparison to international cohorts, adverse clinical event rates were low at 30 days in terms of mortality (0.20%), target lesion revascularisation (TLR, 0.27%) and MACE (0.47%), and at 12 months for mortality (1.26%) TLR (1.16%) and MACE (1.78%). Conclusions: Clinical practice and long-term outcomes of PCI with the Xience DES in Australia are consistent with international series. Recent trends indicate DES use has increased in parallel with good outcomes despite an increasingly complex patient and lesion cohort.

Two-year outcomes from the MitrAl ValvE RepaIr Clinical (MAVERIC) trial: a novel percutaneous treatment of functional mitral regurgitation.

AIMS: We report the 2-year outcomes of the MitrAl ValvE RepaIr Clinical (MAVERIC) trial. Functional mitral regurgitation (FMR) is associated with poor outcomes for which there remains an unmet clinical need. ARTO is a transcatheter annular reduction device for the treatment of FMR and an emerging alternative for patients at high surgical risk. The MAVERIC trial was designed to evaluate the safety and performance of the ARTO system in FMR and heart failure (HF). METHODS AND RESULTS: MAVERIC is an international multicentre, prospective, single arm study enrolling patients with FMR grade ≥ 2, New York Heart Association (NYHA) class ≥II symptoms despite maximal medical therapy. Patients were excluded if they had significant structural mitral valve abnormality or life expectancy <1 year. The primary outcome measures were a composite safety outcome and efficacy defined as mitral regurgitation (MR) reduction 30 days post-procedure. Secondary outcome measures included safety, change in MR grade, NYHA class and hospitalization for HF at 2 years. Forty-five patients were enrolled. The composite safety outcome was met (2/45 adverse events at 30 days) and no device-related deaths occurred at 2-year follow-up. A sustained reduction in MR [grade < 2: 21/31 (68%) vs. 31/31(0%); P < 0.0001], left ventricular end-diastolic volume index (90.0 ± 30 vs. 106 ± 26 mL/m2 ; P = 0.004) and anteroposterior diameter (35.5 ± 4.7 vs. 41.4 ± 4.6 mm; P < 0.0001) was seen at 2 years compared to baseline. Progressive symptomatic improvement [NYHA class ≤II: 27/34 (80%) vs. 12/34 (36%); P < 0.0001] and a reduction in HF hospitalizations (19.8% 2 years post vs. 52.3% 2 years prior; P < 0.001) were seen at 2 years compared to baseline. CONCLUSIONS: The ARTO system is a safe and effective treatment for FMR with reductions in left ventricular end-diastolic volumes sustained to 2 years.

Transcatheter reshaping of the mitral annulus in patients with functional mitral regurgitation: one-year outcomes of the MAVERIC trial.

AIMS: The aim of this study was to assess the one-year safety and efficacy of the transcatheter ARTO system in the treatment of functional mitral regurgitation (FMR). METHODS AND RESULTS: MAVERIC is a multicentre, prospective, non-randomised pre-commercial study. Eligible patients were on guideline-recommended therapy for NYHA Class II-IV systolic heart failure and had an FMR grade ≥2+. The ARTO system was implanted in forty-five (100%) patients. The primary safety composite endpoint (death, stroke, myocardial infarction, device-related surgery, cardiac tamponade, renal failure) at 30 days and one year was 4.4% (95% CI: 1.5-16.6) and 17.8% (95% CI: 9.3-32.4), respectively. Periprocedural complications occurred in seven patients (15.5% [95% CI: 6.5-29.5]), and five patients (11.1% [95% CI: 4.9-24.0]) died during one-year follow-up. Paired results for 36 patients demonstrated that 24 (66.7%) had grade 3+/4+ mitral regurgitation at baseline; however, only five (13.9%) and three (8.3%) patients remained at grade 3+/4+ 30 days and one year post procedure (p<0.0001). Echocardiographic parameters such as anteroposterior annulus diameter decreased from 41.4 mm (baseline) to 36.0 and 35.3 mm at 30 days and one year, respectively (p<0.0001). Twenty-five patients (69.4%) had baseline NYHA Class III/IV symptoms decreasing significantly to nine (25.0%) at 30 days and eight (22.2%) at one year post procedure (p<0.0001). CONCLUSIONS: The ARTO transcatheter mitral valve repair system is both safe and effective in decreasing FMR up to one year post procedure.

The Prophylactic Chimney Snorkel Technique for the Prevention of Acute Coronary Occlusion in High Risk for Coronary Obstruction Transcatheter Aortic Valve Replacement/Implantation Cases.

Coronary occlusion (immediate or delayed) is an uncommon but potentially devastating complication of transcatheter aortic valve replacement/implantation (TAVR/TAVI). Several patient-related, anatomical, device and procedural risk factors can be assessed to risk-stratify patients and assist in procedural planning. In patients at high risk for coronary occlusion, coronary protection measures should be employed. In the highest risk patients, consideration should be given to prophylactic techniques to prevent coronary occlusion. This how-to-do-it report provides a framework for risk assessment for coronary occlusion followed by a step-wise description of the emerging chimney snorkel coronary stenting technique as a predictable procedural approach for the management of this potentially challenging clinical scenario.

Improving Guideline Compliance in Australia With a National Percutaneous Coronary Intervention Outcomes Registry.

BACKGROUND: Secondary prevention strategies after percutaneous coronary intervention (PCI) include statins and dual anti-platelet therapy, however there are significant gaps between guidelines and practice. Contemporary PCI practice requires comprehensive data collection to allow dynamic auditing and benchmarking of key performance and safety indices. Genesis HeartCare is Australia's largest collaborative venture of cardiologists, practising at over 40 public and private hospitals. We hypothesised that measurement and local reporting of data would improve patient outcomes through improving compliance with guideline therapies. METHODS: Real-time benchmarking via a national clinical quality and outcomes register, the Genesis Cardiovascular Outcomes Registry (GCOR-PCI). GCOR-PCI prospectively collected clinical, procedural, medication and outcomes data for 6720 consecutive patients undergoing PCI from 10 private hospitals across Australia. Key performance outcomes benchmarked against the aggregated study cohort and international standards were reported to individual sites. The main outcome measure was compliance with guideline medications (statins, anti-platelet agents). RESULTS: Early data identified specific practice patterns associated with lower rates of statin therapy post-PCI, which led to changes in practice. Between the first and latest year of data collection there was significant improvement in the rates of statin therapy at discharge (92.1 vs. 94.4% p<0.03) and 12 months post-PCI (87.0 vs. 92.2% p<0.001) and of antiplatelet therapy at 12 months (90.7 vs. 94.3% p<0.001). CONCLUSIONS: This large-scale collaboration provides a platform for the development of quality improvement initiatives. Establishment of this clinical quality registry improved patient care by identifying and monitoring gaps in delivery of appropriate therapies, driving key practice change.

Nutritional deficiency of selenium secondary to weight loss (bariatric) surgery associated with life-threatening cardiomyopathy.

Nutritional deficiencies of vitamins and minerals have been associated with reversible and irreversible cardiomyopathic processes. Selenium deficient dilated cardiomyopathy, first described in 1935 in the Keshan Province of China, was sometimes reversed with selenium supplementation. In the past three decades, selenium deficient cardiomyopathy has re-emerged in western medicine secondary to gastrointestinal disorders, long-term total parenteral nutrition (TPN) and gastrointestinal surgery. This report describes a case of selenium deficient cardiomyopathy secondary to the bariatric (weight loss) surgical operation bilio-pancreatic diversion (Scopinaro procedure). This patient presented with life-threatening heart failure nine months after this surgery, having lost 100 kg of body weight. Multiple nutritional deficiencies were detected and corrected including severely depleted selenium levels. Cardiac function and the clinical scenario improved dramatically over three weeks. Screening patients at risk of malnourishment for selenium deficiency as a potential cause of cardiomyopathy is indicated.