Large Left Ventricular Outflow Tract Pseudoaneurysm Closed Percutaneously From a Novel Apical Approach.

An incidental finding of a large left ventricular outflow tract pseudoaneurysm in a 74-year-old man, with high surgical risk, was managed with a novel, fully percutaneous, left ventricular apical approach. The pseudoaneurysm defect and the apical puncture site were successfully closed with Amplatzer septal occluders with successful positioning, as demonstrated on cardiac computed tomography at 6 weeks follow-up. (Level of Difficulty: Intermediate.).

Valve-in-Valve in a Flail Bioprosthetic Mitral Valve With Endocarditis Using a Novel Embolic Protection Device.

A 79-year-old woman presented in cardiogenic shock with a flail bioprosthetic mitral valve leaflet and Staphylococcus aureus endocarditis. In the absence of other viable options, transfemoral valve-in-valve transcatheter mitral valve replacement was performed with a novel embolic protection device, resulting in trace mitral regurgitation and no neurologic complications. (Level of Difficulty: Advanced.).

Comparative analysis of cerebrovascular events in transcatheter and surgical aortic valve replacement: a systematic review and meta-analysis of randomised trials.

AIMS: Transcatheter aortic valve replacement (TAVR) has become the procedure of choice for inoperable patients and a safe alternative to surgical aortic valve replacement (SAVR) among moderate-risk patients. We used meta-analysis to compare the incidence of cerebrovascular events amongst patients undergoing TAVR and SAVR in randomised controlled trials (RCT). METHODS AND RESULTS: Our search revealed five RCT published between 2011 and 2017 with a total of 5,414 patients. Data were summarised as Mantel-Haenszel relative risk (RR) and 95% confidence intervals (CI). The risk of major stroke (RR 0.89, 95% CI: 0.53-1.51), all strokes (RR 0.85, 95% CI: 0.59-1.22) and all cerebrovascular events (RR 0.94, 95% CI: 0.75-1.17) was comparable between patients undergoing TAVR and SAVR at 30 days of follow-up. The risk of all strokes (RR 0.92, 95% CI: 0.69-1.22), major stroke (RR 0.92, 95% CI: 0.62-1.37) and all cerebrovascular events (RR 1.03, 95% CI: 0.79-1.33) was comparable between TAVR and SAVR at one year of follow-up. The incidence of major stroke (RR 1.02, 95% CI: 0.64-1.61), all strokes (RR 1.12, 95% CI: 0.78-1.62) and all cerebrovascular events (RR 1.23, 95% CI: 0.91-1.66) was comparable between TAVR and SAVR between 30 days and one year of follow-up. CONCLUSIONS: In our meta-analysis of RCT comparing TAVR and SAVR, we showed comparable risk of major stroke, all stroke and all cerebrovascular events.

Sex-Specific Outcomes of Transcatheter Aortic Valve Replacement With the SAPIEN 3 Valve: Insights From the PARTNER II S3 High-Risk and Intermediate-Risk Cohorts.

OBJECTIVES: The purpose of this study was to identify sex-specific outcomes of intermediate risk patients undergoing transcatheter aortic valve replacement with the SAPIEN 3 valve. BACKGROUND: A survival difference has been observed in women as compared with men in inoperable and high-risk patients receiving early-generation balloon-expandable valves for transcatheter aortic valve replacement (TAVR). Whether a sex-specific outcome difference persists with newer-generation valves and in lower-risk patients is unknown. METHODS: The PARTNER (Placement of Aortic Transcatheter Valves) II S3 trial included high-risk (HR) (Society of Thoracic Surgeons risk score >8% or heart team determination) and intermediate-risk (IR) (Society of Thoracic Surgeons risk score 4% to 8% or heart team determination) patients with severe symptomatic aortic stenosis who were treated with TAVR with the SAPIEN 3 valve. Patient characteristics and clinical outcomes at 30 days and 1 year were compared by sex. RESULTS: Between October 2013 and December 2014, 1,661 patients were enrolled: 583 were HR (338 men, 245 women) and 1,078 were IR (666 men, 412 women). In both cohorts, women were more likely than men to be frail (22% vs. 13%; p < 0.001), but less likely to have comorbid conditions of renal insufficiency, coronary artery disease, atrial fibrillation, or chronic obstructive pulmonary disease. Women were more likely to receive ≤23-mm valves (74.1% vs. 11.1%; p < 0.001) and were less likely to receive 29-mm valves (1.4% vs. 35.1%; p < 0.001). In the combined cohorts, there was no difference in mortality for women compared with men at 30 days (2.0% vs. 1.2%; p = 0.20) or 1 year (9.3% vs. 10.2%; p = 0.59). There were no differences in disabling stroke or any stroke at 30 days or 1 year; however, women had an increased rate of minor stroke at 30 days (2.1% vs. 0.7%; p = 0.01). Female sex was associated with increased major vascular complications (7.9% vs. 4.4%; p = 0.003), but not with moderate or severe paravalvular regurgitation. Notably, similar outcomes regarding sex-specific outcomes were obtained within stratified analyses of the HR and IR cohorts. CONCLUSIONS: The study found no apparent sex-specific differences in survival or stroke in this trial of TAVR. This may reflect the changing demographic of patients enrolled, use of newer-generation valves with more sizes available, and more accurate valve sizing techniques.

Clinical and Echocardiographic Outcomes Following Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement: Meta-Analysis and Meta-Regression.

BACKGROUND: Transcatheter aortic valve replacement has become the procedure of choice for inoperable, high-risk, and many intermediate-risk patients with aortic stenosis. Conduction abnormalities are a common finding after transcatheter aortic valve replacement and often result in permanent pacemaker (PPM) implantation. Data pertaining to the clinical impact of PPM implantation are controversial. We used meta-analysis techniques to summarize the effect of PPM implantation on clinical and echocardiographic outcomes after transcatheter aortic valve replacement. METHODS AND RESULTS: Data were summarized as Mantel-Haenszel relative risk (RR) and 95% confidence intervals (CIs) for dichotomous variables and as standardized mean difference and 95% CI for continuous variables We used the Higgins I2 statistic to evaluate heterogeneity. We found that patients with and without PPM have similar all-cause mortality (RR, 0.85; 95% CI, 0.70-1.03), cardiovascular mortality (RR, 0.84; 95% CI, 0.59-1.18), myocardial infarction (RR, 0.47; 95% CI, 0.20-1.11), and stroke (RR, 1.26; 95% CI, 0.70-2.26) at 30 days. The groups were also comparable in all-cause mortality (RR, 1.03; 95% CI, 0.92-1.16), cardiovascular mortality (RR, 0.69; 95% CI, 0.39-1.24), myocardial infarction (RR, 0.58; 95% CI, 0.30-1.13), and stroke (RR, 0.70; 95% CI, 0.47-1.04) at 1 year. We observed that the improvement in left ventricular ejection fraction was significantly greater in the patients without PPM (standardized mean difference, 0.22; 95% CI, 0.12-0.32). CONCLUSIONS: PPM implantation is not associated with increased risk of all-cause mortality, cardiovascular mortality, stroke, or myocardial infarction both at short- and long-term follow-up. However, PPM is associated with impaired left ventricular ejection fraction recovery post-transcatheter aortic valve replacement.

Transcatheter Aortic Valve Implantation Within Degenerated Aortic Surgical Bioprostheses: PARTNER 2 Valve-in-Valve Registry.

BACKGROUND: Early experience with transcatheter aortic valve replacement (TAVR) within failed bioprosthetic surgical aortic valves has shown that valve-in-valve (VIV) TAVR is a feasible therapeutic option with acceptable acute procedural results. OBJECTIVES: The authors examined 30-day and 1-year outcomes in a large cohort of high-risk patients undergoing VIV TAVR. METHODS: Patients with symptomatic degeneration of surgical aortic bioprostheses at high risk (≥50% major morbidity or mortality) for reoperative surgery were prospectively enrolled in the multicenter PARTNER (Placement of Aortic Transcatheter Valves) 2 VIV trial and continued access registries. RESULTS: Valve-in-valve procedures were performed in 365 patients (96 initial registry, 269 continued access patients). Mean age was 78.9 ± 10.2 years, and mean Society of Thoracic Surgeons score was 9.1 ± 4.7%. At 30 days, all-cause mortality was 2.7%, stroke was 2.7%, major vascular complication was 4.1%, conversion to surgery was 0.6%, coronary occlusion was 0.8%, and new pacemaker insertion was 1.9%. One-year all-cause mortality was 12.4%. Mortality fell from the initial registry to the subsequent continued access registry, both at 30 days (8.2% vs. 0.7%, respectively; p = 0.0001) and at 1 year (19.7% vs. 9.8%, respectively; p = 0.006). At 1 year, mean gradient was 17.6 mm Hg, and effective orifice area was 1.16 cm2, with greater than mild paravalvular regurgitation of 1.9%. Left ventricular ejection fraction increased (50.6% to 54.2%), and mass index decreased (135.7 to 117.6 g/m2), with reductions in both mitral (34.9% vs. 12.7%) and tricuspid (31.8% vs. 21.2%) moderate or severe regurgitation (all p < 0.0001). Kansas City Cardiomyopathy Questionnaire score increased (mean: 43.1 to 77.0) and 6-min walk test distance results increased (mean: 163.6 to 252.3 m; both p < 0.0001). CONCLUSIONS: In high-risk patients, TAVR for bioprosthetic aortic valve failure is associated with relatively low mortality and complication rates, improved hemodynamics, and excellent functional and quality-of-life outcomes at 1 year. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves [PARTNER II]; NCT01314313).

Impact of Coronary Artery Disease Severity Assessed With the SYNTAX Score on Outcomes Following Transcatheter Aortic Valve Replacement.

BACKGROUND: The influence of coronary artery disease (CAD) on clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR) is still controversial. We sought to evaluate the impact of CAD severity as measured by the SYNTAX score (SS) on patients undergoing TAVR. METHODS AND RESULTS: A total of 377 patients who underwent TAVR in 2 high-volume centers in North America were included in our retrospective analysis. A blinded angiographic core laboratory calculated the SS on all available coronary angiograms with the use of quantitative coronary analysis. Patients were stratified into 4 groups: (1) no CAD (SS=0); (2) low SS (SS between 1 and 22); (3) intermediate SS (SS between 23 and 32); and (4) high SS (SS ≥33). Patients who had undergone percutaneous coronary intervention within 6 months prior to TAVR were separated into 2 categories based on their residual SS (<8 and ≥8). Patients with previous coronary artery bypass grafting (CABG) were divided into 2 groups: (1) low CABG SS and (2) high CABG SS. The primary end point was a composite of all-cause mortality, myocardial infarction, and stroke. At 30 days and 1 year, both the presence and the severity of CAD had no impact on the rate of the combined primary end point and on all-cause mortality, cardiovascular mortality, and myocardial infarction. Patients with less complete revascularization (residual SS ≥8 versus residual SS <8 and low CABG SS versus high CABG SS, had similar rates of the combined primary end point, all-cause mortality, cardiovascular mortality, MI, and stroke, at both 30 days and 1 year. CONCLUSIONS: In our core laboratory-validated study, neither the severity of CAD nor completeness of revascularization after percutaneous coronary intervention or CABG were associated with clinical outcomes after TAVR, at both 30 days and 1 year.

Impact of Methodologic Differences in Three-Dimensional Echocardiographic Measurements of the Aortic Annulus Compared with Computed Tomographic Angiography Before Transcatheter Aortic Valve Replacement.

BACKGROUND: Three-dimensional (3D) echocardiographic (3DE) imaging is an alternative to multi-detector row computed tomography (MDCT) for aortic annular measurement before transcatheter aortic valve replacement (TAVR). A commonly used direct planimetry from a reconstructed short-axis view has not been compared with semiautomated 3DE methods. Typically accepted optimal cutoffs for percent prosthesis-area oversizing of the balloon-expandable SAPIEN or SAPIEN XT valve to native annular size are approximately 5% to 15%. The aim of this study was to compare semiautomated and direct planimetric 3DE methods for aortic annular sizing with a gold standard of MDCT to determine predictive value for paravalvular regurgitation (PVR) and balloon postdilatation. METHODS: In this retrospective analysis, aortic annular cross-sectional area was measured from pre-TAVR imaging using (1) MDCT (CT_Area), (2) a 3D transesophageal echocardiographic (TEE) semiautomated method (3DE_Area_SA), and (3) a 3D TEE direct planimetric method (3DE_Area_Direct). Annular area percent oversizing was calculated. PVR after TAVR was assessed from intraoperative TEE imaging. Need for balloon postdilatation was recorded. RESULTS: One hundred patients who underwent TAVR with either the SAPIEN or SAPIEN XT balloon-expandable prosthesis were analyzed. Twenty-three patients had mild or greater PVR after TAVR. CT_Area was 442 ± 79 mm2, 3DE_Area_SA was 435 ± 81 mm2, and 3DE_Area_Direct was 429 ± 82 mm2. Both 3DE_Area_SA and 3DE_Area_Direct underestimated MDCT (P < .05). All methods were highly correlative (R = 0.88-0.93, P < .0001). Percent oversizing obtained by the three methods significantly predicted mild or greater PVR and need for balloon postdilatation by receiver operating characteristic analysis, with optimal cutoffs for CT_Area (9%-10%) and 3DE_Area_SA (14%) within the recommended ranges for the studied transcatheter valves and for 3DE_Area_Direct higher than the recommended range (18%-19%). Inter- and intraobserver reproducibility were lowest for 3DE_Area_Direct. CONCLUSIONS: Caution must be used when using 3D TEE direct planimetry of the aortic annulus, as optimal percent oversizing ranges approach the level associated with root injury, and measurements are less reproducible. Therefore, semiautomated 3DE planimetry is preferred to 3DE direct planimetry for aortic annulus sizing.

Intra-aortic balloon counterpulsation in contemporary practice - where are we?

The intra-aortic balloon pump (IABP) remains the most widely used form of mechanical circulatory support in current clinical practice. This article will review the current evidence to guide IABP use, focussing on large registry and prospective, randomised data, and seek to establish appropriate roles for the IABP in contemporary practice. Despite a paucity of clinical evidence, the IABP remains a useful clinical tool in selected settings, although its routine, up-front use in relatively unselected MI populations is not supported by data. Although current evidence no longer supports routine use in certain high-risk groups, further studies of appropriately selected high-risk patients may yet demonstrate benefit in patients with moderate-severe degrees of shock.

High-sensitivity troponin level pre-catheterization predicts adverse cardiovascular outcomes after primary angioplasty for ST-elevation myocardial infarction.

BACKGROUND: Cardiac troponins are the preferred biomarkers for diagnosing myocardial infarction (MI). High-sensitivity troponin T (hs-TnT) assays have increased sensitivity and enable more rapid diagnosis of infarction. We assessed the prognostic utility of admission hs-TnT to detect outcomes after primary angioplasty for ST-elevation/new left bundle branch block myocardial infarction (STEMI). METHODS: Patients admitted to Auckland City Hospital for acute coronary catheterization with a diagnosis of STEMI between October 2010 and September 2011 were identified, and included if hs-TnT levels were measured at admission. Clinical characteristics and major adverse cardiovascular events (MACE: death, myocardial infarction and revascularization) at 30 days and 1 year were collected from national statistics and electronic medical records. RESULTS: Median admission hs-TnT level in the 173 STEMI patients studied was 59 ng/L (interquartile range (IQR) 19-310). Incidences of MACE at 30 days and 1 year were 10% (n=17) and 18% (n=31), respectively. C-statistics and 95% confidence interval (CI) (95% CI) for hs-TnT on admission at detecting MACE at 30 days and 1 year were 0.800 (0.696-0.904) and 0.750 (0.655-0.845) respectively, with the optimal cut-point of 225 ng/L giving sensitivities/specificities of 76.5%/75.6% and 64.5%/78.2% respectively. Admission log(hs-TnT) independently predicted both MACE at 30 days with hazards ratio 5.16, 95% CI (2.25-11.9) and 1 year with hazards ratio 2.88, 95% CI (1.79-4.63), as did age and cardiogenic shock. Age, Maori or Pacific ethnicity and chronic respiratory disease were independent predictors of hs-TnT>225 ng/L. CONCLUSION: Admission hs-TnT measured in primary angioplasty is strongly prognostic of MACE at 30 days and 1 year, even following adjustment for potential confounding variables.

Patent foramen ovale closure in the treatment of obstructive sleep apnea.

Obstructive sleep apnea (OSA) and patent foramen ovale (PFO) are common conditions and may coexist. In patients with OSA, increases in right-to-left shunting across a PFO may result in increased burden of hypoxia, although the effect of this is unknown. We report the cases of 3 patients with highly symptomatic OSA and PFO who underwent percutaneous closure with the Coherex FlatStent PFO Closure System. Although PFO closure can be achieved with minimally invasive techniques and low rates of adverse events, its importance in reducing hypoxia in this population is unknown. PFO closure may result in improvement in apneas and symptoms in selected OSA patients and may impact cardiovascular events in this group through hypoxia-mediated or other unrecognized mechanisms.

Renal denervation for resistant hypertension using an irrigated radiofrequency balloon: 12-month results from the Renal Hypertension Ablation System (RHAS) trial.

AIMS: Renal denervation using the point-by-point application of radiofrequency energy delivered by the first-generation Symplicity system is effective in lowering office blood pressure but may be time-consuming. The OneShot Renal Denervation System with a balloon-mounted spiral electrode potentially shortens and simplifies the procedure. This study is a hypothesis-generating first-in-human study to assess feasibility, and to provide preliminary efficacy and safety data. METHODS AND RESULTS: Eligible patients had a baseline office systolic blood pressure ≥160 mmHg (or ≥150 mmHg for diabetics) and were on two or more antihypertensive medications. Nine patients were enrolled. The primary endpoint, the insertion of the OneShot balloon into each renal artery and the delivery of radiofrequency energy, was achieved in 8/9 (89%) of patients. The one failure (the first patient) was due to generator high-impedance safety shut-off threshold set too low for humans. Adverse events were minor. No patient developed renal artery stenosis. Baseline BP was 185.67 ± 18.7 mmHg and the reductions at 1, 3, 6 and 12 months were 30.1 ± 13.6 (p=0.0004), 34.2 ± 20.2 (p=0.002), 33.6 ± 32.2 (p=0.021) and 30.6 ± 22.0 (p=0.019). CONCLUSIONS: The OneShot renal denervation system successfully delivered radiofrequency energy to the renal arteries in a short and straightforward procedure. Australian New Zealand Clinical Trials Registry - URL: anzctr.org.au. Trial identification: ACTRN12611000987965.

Safety and feasibility of patient transfer by helicopter for primary percutaneous coronary intervention.

AIM: Delayed treatment of patients undergoing transfer for primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI) may reduce treatment benefits compared with fibrinolysis at the referring institution. We evaluated the feasibility of helicopter transfer of Whangarei patients to Auckland City Hospital for PPCI. METHOD: Clinical records of patients transferred from Whangarei to Auckland City Hospital by helicopter for PPCI were reviewed and clinical data reported. RESULTS: Between May 2010 and August 2011, 24 patients (19 male, median age 63 years, range 41-79 years) underwent helicopter transfer PPCI from Whangarei. Overall, median time to reperfusion was 125 minutes (IQR 117-147 minutes). For the 9 patients presenting within working hours (weekdays 8am-5pm), the median reperfusion time was 122 minutes (IQR 105-136 minutes), compared with 134 minutes (IQR 117-159 minutes) in the 15 patients presenting outside working hours. One patient achieved reperfusion within 90 minutes from presentation while 8/24 achieved reperfusion within 120 minutes. All patients survived to hospital discharge, as did 23/24 at 30 day follow-up. CONCLUSION: Helicopter transfer for PPCI from Whangarei to Auckland City Hospital is a feasible treatment strategy for patients presenting with STEMI. Improvements in treatment times are required if the full benefits of this strategy are to be realised.