Bifurcation left main stenting with or without intracoronary imaging: Outcomes from the EBC MAIN trial.

BACKGROUND: The impact of intracoronary imaging on outcomes, after provisional versus dual-stenting for bifurcation left main (LM) lesions, is unknown. OBJECTIVES: We investigated the effect of intracoronary imaging in the EBC MAIN trial (European Bifurcation Club LM Coronary Stent study). METHODS: Four hundred and sixty-seven patients were randomized to dual-stenting or a stepwise provisional strategy. Four hundred and fifty-five patients were included. Intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was undertaken at the operator's discretion. The primary endpoint was death, myocardial infarction or target vessel revascularization at 1-year. RESULTS: Intracoronary imaging was undertaken in 179 patients (39%; IVUS = 151, OCT = 28). As a result of IVUS findings, operators reintervened in 42 procedures. The primary outcome did not differ with intracoronary imaging versus angiographic-guidance (17% vs. 16%; odds ratio [OR]: 0.92 (95% confidence interval [CI]: 0.51-1.63) p = 0.767), nor for reintervention based on IVUS versus none (14% vs. 16%; OR: 0.88 [95% CI: 0.32-2.43] p = 0.803), adjusted for syntax score, lesion calcification and ischemic symptoms. With angiographic-guidance, primary outcome events were more frequent with dual versus provisional stenting (21% vs. 10%; adjusted OR: 2.11 [95% CI: 1.04-4.30] p = 0.039). With intracoronary imaging, there were numerically fewer primary outcome events with dual versus provisional stenting (13% vs. 21%; adjusted OR: 0.56 [95% CI: 0.22-1.46] p = 0.220). CONCLUSIONS: In EBC MAIN, the primary outcome did not differ with intracoronary imaging versus none. However, in patients with angiographic-guidance, outcomes were worse with a dual-stent than provisional strategy When intracoronary imaging was used, there was a trend toward better outcomes with the dual-stent than provisional strategy.

Impact of technique on bifurcation stent outcomes in the European Bifurcation Club Left Main Coronary Trial.

BACKGROUND: Techniques for provisional and dual-stent left main bifurcation stenting require optimization. AIM: To identify technical variables influencing procedural outcomes and periprocedural myocardial infarction following left main bifurcation intervention. METHODS: Procedural and outcome data were analyzed in 438 patients from the per-protocol cohort of the European Bifurcation Club Left Main Trial (EBC MAIN). These patients were randomized to the provisional strategy or a compatible dual-stent extension (T, T-and-protrude, or culotte). RESULTS: Mean age was 71 years and 37.4% presented with an acute coronary syndrome. Transient reduction of side vessel thrombolysis in myocardial infarction flow occurred after initial stent placement in 5% of procedures but was not associated with periprocedural myocardial infarction. Failure to rewire a jailed vessel during any strategy was more common when jailed wires were not used (9.5% vs. 2.5%, odds ratio [OR]: 6.4, p = 0.002). In the provisional cohort, the use of the proximal optimization technique was associated with less subsequent side vessel intervention (23.3% vs. 41.9%, OR: 0.4, p = 0.048). Side vessel stenting was predominantly required for dissection, which occurred more often following side vessel preparation (15.3% vs. 4.4%, OR: 3.1, p = 0.040). Exclusive use of noncompliant balloons for kissing balloon inflation was associated with reduced need for side vessel intervention in provisional cases (20.5% vs. 38.5%, OR: 0.4, p = 0.013), and a reduced risk of periprocedural myocardial infarction across all strategies (2.9% vs. 7.7%, OR: 0.2, p = 0.020). CONCLUSION: When performing provisional or compatible dual-stent left main bifurcation intervention, jailed wire use is associated with successful jailed vessel rewiring. Side vessel preparation in provisional patients is linked to increased side vessel dissection requiring stenting. Use of the proximal optimization technique may reduce the need for additional side vessel intervention, and noncompliant balloon use for kissing balloon inflation is associated with a reduction in both side vessel stenting and periprocedural myocardial infarction. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02497014.

Feasibility of transcaval access TAVI in morbidly obese patients: A single-center experience.

OBJECTIVES: We report a single-center experience in utilizing the transcaval-access transcatheter aortic valve implantation (TAVI) as an alternative approach in morbidly obese patients. BACKGROUND: Morbidly obese patients present frequently for TAVI. Transfemoral arterial access TAVI in these patients is technically challenging due to deep arterial access, resulting in a higher risk of vascular complications. Transcaval access TAVI is increasingly used in patients with prohibitive iliofemoral arterial access. METHODS: We used the transcaval approach for eight morbidly obese patients who had otherwise technically feasible femoral arterial access. This technique provides an alternative arterial access point that potentially circumvents some of the challenges relating to femoral arterial access. RESULTS: We report eight morbidly obese patients with a mean body mass index of 42.3 ± 6.2 kg/m2 who underwent transcaval access TAVI at our center (mean EuroScore II 2.47 ± 1.83%). The patient mean age was 70.3 ± 9.8 years; six were female. All eight patients underwent a successful and uncomplicated procedure. The median time to discharge was 2 days and all patients were alive at 30 days. CONCLUSIONS: Transcaval access TAVI is a feasible alternative for morbidly obese patients and may reduce vascular complications. Further data are required to evaluate the safety of this approach.

Mobility aids predict mortality after transcatheter aortic valve implantation.

BACKGROUND: Selection of appropriate patients for transcatheter aortic valve implantation (TAVI) can be challenging. Many factors can influence post-procedure outcomes. Traditional surgical scoring systems do not discriminate effectively. Medical parameters and functional indices can characterize mortality risk. Mobility is an important predictive functional index but is largely defined using subjective criteria. AIM: To describe the relationship between mobility, objectively defined by the requirement for gait aids to ambulate, and all-cause 30-day and long-term mortality in patients undergoing TAVI. METHODS: Mobility aid use was assessed in 1444 consecutive patients undergoing TAVI in a single center. Patients were categorized into "unaided," "1-stick," and "higher aid" groups based on the Brighton Mobility Index. Mortality tracking was obtained via the NHS Spine Portal in February 2021. RESULTS: Patients were aged 82 (IQR 78-86). 66% of patients walked unaided, 26% walked with 1 stick, and 8% required more assistance (e.g., 2 sticks, a Rollator, a Zimmer frame, or a wheelchair). Overall 30-day mortality for the whole cohort was 3.5%; 1-year mortality was 12.2%. Mobility was a significant predictor of 30-day mortality (p = 0.025). Use of a higher aid was associated with a mortality odds ratio of 2.83 (95% CI: 1.39-5.74). Mobility was also a significant predictor of long-term mortality (p < 0.001). Odds ratios for 1-stick and higher aid groups were 1.45 (95% CI: 1.21-1.72) and 2.01 (95% CI: 1.55-2.60), respectively. CONCLUSION: Objective assessment of mobility by gait aid use predicts both short and long-term survival in patients undergoing TAVI. Increased dependence on mobility aids is associated with a worse prognosis.

SMARTphone-based, early cardiac REHABilitation in patients with acute coronary syndromes [SMART-REHAB Trial]: a randomized controlled trial protocol.

BACKGROUND: There are well-documented treatment gaps in secondary prevention of coronary heart disease and no clear guidelines to assist early physical activity after acute coronary syndromes (ACS). Smartphone technology may provide an innovative platform to close these gaps. This paper describes the study design of a randomized controlled trial assessing whether a smartphone-based secondary prevention program can facilitate early physical activity and improve cardiovascular health in patients with ACS. METHODS: We have developed a multi-faceted, patient-centred smartphone-based secondary prevention program emphasizing early physical activity with a graduated walking program initiated on discharge from ACS admission. The program incorporates; physical activity tracking through the smartphone's accelerometer with interactive feedback and goal setting; a dynamic dashboard to review and optimize cardiovascular risk factors; educational messages delivered twice weekly; a photographic food diary; pharmacotherapy review; and support through a short message service. The primary endpoint of the trial is change in exercise capacity, as measured by the change in six-minute walk test distance at 8-weeks when compared to baseline. Secondary endpoints include improvements in cardiovascular risk factor status, psychological well-being and quality of life, medication adherence, uptake of cardiac rehabilitation and re-hospitalizations. DISCUSSION: This randomized controlled trial will use a smartphone-phone based secondary prevention program to emphasize early physical activity post-ACS. It will provide evidence regarding the feasibility and utility of this innovative platform in closing the treatment gaps in secondary prevention. TRIAL REGISTRATION: The trial was retrospectively registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) on April 4, 2016. The registration number is ACTRN12616000426482 .

Impact of commissural versus coronary alignment on risk of coronary obstruction following transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) with commissural alignment aims to limit the risk of coronary occlusion and maintain good coronary access. However, due to coronary origin eccentricity within the coronary cusp, coronary-commissural overlap (CCO) may still occur. TAVI using coronary alignment, rather than commissural alignment, may further improve coronary access. To compare rates of CCO after TAVI using commissural versus coronary alignment methodology. Cardiac CT scans from 102 patients with severe (tricuspid) aortic stenosis referred for TAVI were analysed. Native cusp asymmetry and coronary eccentricity were defined and used to simulate TAVI using commissural versus coronary alignment. Rates of optimal coronary alignment (< 10° from cusp centre) and severe misalignment (< 15° from coronary-commissural overlap) were compared. Additionally, the impact of valve misalignment during implantation was assessed. The native right coronary artery (RCA) origin was 15.8° (9.5 to 24°) closer to the right coronary cusp/non-coronary cusp (RCC-NCC) commissure than the centre of the right coronary cusp. The native left coronary artery (LCA) origin was 4.5° (0 to 11.5°) closer to the left coronary cusp/non-coronary cusp (LCC-NCC) commissure than the centre of the left coronary cusp (p < 0.01). Compared to commissural alignment, coronary alignment doubled the proportion of optimally-aligned RCAs (62/102 [60.8%] vs. 31/102 [30.4%]; p < 0.001), without a significant change in optimal LCA alignment (62/102 [60.8% vs. 74/102 [72.6%]; p = 0.07). There were no cases of severe misalignment with either strategy. Simulating 15° of valve misalignment resulted in severe RCA compromise risk in 7/102 (6.9%) of commissural alignment cases, compared to none using coronary alignment. Fluoroscopic projection was similar with both approaches. Coronary alignment resulted in a 2-fold increase of optimal TAVI positioning relative to the RCA ostium when compared to commissural alignment without impacting the LCA. Use of coronary alignment rather than commissural alignment may improve coronary access after TAVI and is less sensitive to valve rotational error, particularly for the right coronary artery.

Optical frequency domain imaging (OFDI) represents a novel technique for the diagnosis of giant cell arteritis.

BACKGROUND/OBJECTIVES: Giant cell arteritis (GCA) is an inflammatory vascular disease in which prompt and accurate diagnosis is critical. The efficacy of temporal artery biopsy (TAB) is limited by 'skip' lesions and a delay in histological analysis. This first-in-man ex-vivo study aims to assess the accuracy of optical frequency domain imaging (OFDI) in diagnosing GCA. SUBJECTS/METHODS: 29 TAB samples of patients with suspected GCA were submerged in 0.9% sodium chloride and an OFDI catheter was passed through the lumen to create cross-sectional images prior to histological analysis. The specimens were then preserved in formalin for histological examination. Mean intimal thickness (MIT) on OFDI was measured, and the presence of both multinucleate giant cells (MNGCs) and fragmentation of the internal elastic lamina (FIEL) was assessed and compared with histology, used as the diagnostic gold standard. RESULTS: MIT in patients with/without histological evidence of GCA was 0.425 mm (±0.43) and 0.13 mm (±0.06) respectively compared with 0.215 mm (±0.09) and 0.135 mm (±0.07) on OFDI. MIT measured by OFDI was significantly higher in patients with histologically diagnosed arteritis compared to those without (p = 0.0195). For detecting FIEL and MNGCs, OFDI had a sensitivity of 75% and 28.6% and a specificity of 100% and 77.3% respectively. Applying diagnostic criteria of MIT > 0.20 mm, or the presence of MNGCs or FIEL, the sensitivity of detecting histological arteritis using OFDI was 91.4% and the specificity 94.1%. CONCLUSIONS: OFDI provided rapid imaging of TAB specimens achieving a diagnostic accuracy comparable to histological examination. In-vivo imaging may allow imaging of a longer arterial section.

The Impact of Cerebral Embolic Protection Devices on Characteristics and Outcomes of Stroke Complicating TAVR.

BACKGROUND: Acute ischemic stroke remains a serious complication of transcatheter aortic valve replacement (TAVR). Cerebral embolic protection devices (CEPD) were developed to mitigate the risk of acute ischemic stroke complicating TAVR (AISCT). However, the existing body of evidence does not clearly support CEPD efficacy in AISCT prevention. OBJECTIVES: In a cohort of patients with AISCT, we aimed to compare the characteristics and outcomes of patients who have had unprotected TAVR (CEPD-) vs CEPD-protected TAVR (CEPD+). METHODS: Data were derived from an international multicenter registry focusing on AISCT. We included all patients who experienced ischemic stroke within 72 hours of TAVR. Stroke severity was assessed using the National Institutes of Health Stroke Scale (NIHSS). Primary outcomes were neurologic disability status according to the modified Rankin Score at 30 days, and 6-month all-cause death. Propensity score matched analysis was used to control for differences between groups. RESULTS: In 18,725 TAVR procedures, 416 AISCT (2.2%) within 72 hours were documented, of which 376 were in the CEPD- TAVR group and 40 in the CEPD+ TAVR group. Although the middle cerebral artery stroke rate was similar in both groups (29.7% CEPD- vs 33.3% CEPD+; P = 0.71), AISCT in the CEPD+ group was characterized by a lower rate of internal carotid artery occlusion (0% vs 4.7%) and higher rate of vertebrobasilar system strokes (15.4% vs 5.7%; P = 0.04). AISCT was severe (NIHSS ≥15) in 21.6% CEPD- and 23.3% CEPD+ AISCT (P = 0.20). Disabling stroke rates (modified Rankin Score >1 at 30 days) were 47.3% vs 42.5% (P = 0.62), and 6-month mortality was 31.3% vs 23.3% (P = 0.61), in the CEPD- and CEPD+ groups, respectively. In the propensity score matched cohort, disabling stroke rates were 56.5% vs 41.6% (P = 0.16), and 6-month mortality was 33% vs 19.5% (P = 0.35), in the CEPD- and CEPD+ groups, respectively. CONCLUSIONS: In a large cohort of patients with AISCT, the use of CEPD had little effect on stroke distribution, severity, and outcomes.

Novel adaptations in percutaneous right transaxillary access for transcatheter aortic valve implantation using the sapien ultra valve.

BACKGROUND: Percutaneous transaxillary access is used as an alternative to the transfemoral approach for transcatheter aortic valve implantation in patients with severe peripheral vascular disease. The left transaxillary approach is usually preferred due to ease of valve alignment with the aortic annulus. Some patients have anatomical and physiological factors which preclude this approach. Moreover, most catheterization lab layouts make left-sided approaches to the heart awkward for imaging, visualization, procedural ease, and radiation protection. AIMS: The authors describe novel adaptations to allow successful right transaxillary access for implantation of the transcatheter heart valve using the Edwards Sapien 3 system (Edwards Lifesciences). METHODS: We searched our local structural heart database for all patients who underwent transcatheter aortic valve implantation via axillary access, from January 2021 to January 2022. Patients with left axillary access were excluded. RESULTS: We report 6 percutaneous right transaxillary cases performed in the last year using steps which allow smooth delivery of the SAPIEN 3 Ultra valve down the greater curvature of the aorta and providing co-axial alignment of the valve. Only one patient had a vascular complication with arterial dissection at the closure point managed with 8 mm x 37 mm Bentley uncovered stent at the access site. CONCLUSION: With the modifications described in our article, the right transaxillary approach has now become our preferred secondary access route for TAVI.

Transcatheter Aortic Valve Implantation in Patients With Right Bundle-Branch Block: Should Prophylactic Pacing Be Undertaken?

INTRODUCTION: Right bundle-branch block (RBBB) is a strong predictor of the development of high-grade AV block (AVB) after TAVI. AIMS: To assess mortality, length-of-hospital stay, and cost in patients with RBBB undergoing TAVI according to whether or not they had preprocedural permanent pacemaker (PPM) implantation. METHODS AND RESULTS: A total of 121 patients with RBBB who underwent TAVI between 2009-2021 were included. A total of 41 patients (33.9%) received a prophylactic PPM by clinical preference and 45/80 patients (56%) received PPM after TAVI. Baseline characteristics were balanced. Mortality was similar at 5 years, with death in 17 patients (41.4%) in the prophylactic PPM group vs 27 (33.8%) in the no prophylactic PPM group (adjusted hazard ratio [HR], 1.27; 95% confidence interval [CI], 0.69-2.33; P=.44). Median survival for the prophylactic PPM (4.2 years), post TAVI PPM (4.5 years) and no pacemaker (4.7 years) groups was similar. Sixteen deaths (35.6%) occurred in those receiving PPM after TAVI and 11 deaths (31.4%) occurred in those not receiving PPM (HR, 0.95; 95% CI, 0.43-2.09; P=.90). Thirty-day all-cause mortality was similar. Compared with post-TAVI PPM, prophylactic PPM reduced hospital length of stay (4.3 ± 4.5 days vs 2.5 ± 1.6 days, respectively; P=.02). For the highest and lowest complication and comorbidity scores, prophylactic PPM resulted in cost savings of £297.32 (-2.9%) and excess cost of £423.89 (+5.6%), respectively. There were no major pacing-related complications. CONCLUSIONS: More than half of patients with RBBB undergoing TAVI require PPM shortly after their valve implant. A prophylactic pacing strategy is safe, reduces length of hospital stay, and is cost effective in the United Kingdom.

Redo Transcatheter Aortic Valve Implantation in the Lotus Mechanically Expanded Transcatheter Heart Valve: Bench-Top Analysis, Clinical Experience, and Procedural Guidance.

BACKGROUND: Redo transcatheter aortic valve implantation (TAVI) is increasing as patients outlive their transcatheter heart valves (THVs) and present with bioprosthetic valve failure. The Lotus mechanically expanded THV has unique design characteristics, which have specific implications for Redo TAVI. METHODS: The design features of the Lotus valve and their relevance to Redo TAVI were reviewed. Bench-top analysis of Redo TAVI was performed using different contemporary THVs. Procedural and outcome data were obtained from 10 patients who had undergone Redo TAVI for Lotus bioprosthetic valve failure in 5 centers. Recommendations for performing Redo TAVI in Lotus are made, based on these findings. RESULTS: The Lotus leaflets extend from the frame inflow, with a Neoskirt of only 13 mm, hence a low risk of coronary obstruction during Redo TAVI. The Lotus frame posts prevent full apposition of the Redo prosthesis in the upper part of the frame, while implantation of the Redo THV above the Lotus inflow leads to inadequate apposition of the Lotus leaflets. Inflow-to-inflow positioning is therefore recommended for effective sealing and leaflet pinning. The Lotus locking mechanism prevents overexpansion of the frame, limiting Redo THV oversizing. Redo TAVI was favorable with SAPIEN 3, Evolut, and Navitor THVs on bench-top analysis but not with ACURATE Neo 2 due to the upper crowns and short stent preventing inflow-to-inflow deployment. Case review demonstrated satisfactory outcomes in 10 patients treated with Evolut (n=6), SAPIEN 3 (n=3), and Portico (n=1) valves, with no mortality, major morbidity, or coronary obstruction. Three patients had residual mean gradient ≥20 mm Hg, including 2 of 3 SAPIEN cases. Guidance on procedural planning, valve choice, sizing, and positioning is provided. CONCLUSIONS: Redo TAVI in Lotus requires an understanding of unique design characteristics, and adherence to key procedural recommendations, but can be safely and effectively performed with most contemporary valve types.

Stepwise provisional versus systematic culotte for stenting of true coronary bifurcation lesions: five-year follow-up of the multicentre randomised EBC TWO Trial.

BACKGROUND: The multicentre European Bifurcation Club Trial (EBC TWO) showed no significant differences in 12-month clinical outcomes between patients randomised to a provisional stenting strategy or systematic culotte stenting in non-left main true bifurcations. AIMS: This study aimed to investigate the 5-year clinical results of the EBC TWO Trial. METHODS: A total of 200 patients undergoing stent implantation for non-left main bifurcation lesions were recruited into EBC TWO. Inclusion criteria required a side branch diameter ≥2.5 mm and side branch lesion length >5 mm. Five-year follow-up was completed for 197 patients. The primary endpoint was the composite of all-cause mortality, myocardial infarction, or target vessel revascularisation. RESULTS: The mean side branch stent diameter was 2.7±0.3 mm and mean side branch lesion length was 10.3±7.2 mm. At 5-year follow-up, the primary endpoint occurred in 18.4% of provisional and 23.7% of systematic culotte patients (hazard ratio [HR] 0.75, 95% confidence interval [CI]: 0.41-1.38). No significant differences were identified individually for all-cause mortality (7.8% vs 7.2%, HR 1.11, 95% CI: 0.40-3.05), myocardial infarction (8.7% vs 13.4%, HR 0.64, 95% CI: 0.27-1.50) or target vessel revascularisation (6.8% vs 9.3%, HR 1.12, 95% CI: 0.37-3.34). Stent thrombosis rates were also similar (1.9% vs 3.1%, HR 0.63, 95% CI: 0.11-3.75). There was no significant interaction between the extent of side branch disease and the primary outcome (p=0.34). CONCLUSIONS: In large non-left main true bifurcation lesions, the use of a systematic culotte strategy showed no benefit over provisional stenting for the composite outcome of all-cause mortality, myocardial infarction, or target vessel revascularisation at 5 years. The stepwise provisional approach may be considered preferable for the majority of true coronary bifurcation lesions. CLINICALTRIALS: gov: NCT01560455.

Percutaneous coronary intervention of bifurcation lesions.

Bifurcation coronary artery disease is common as the development of atherosclerosis is facilitated by altered endothelial shear stress. Multiple anatomical and physiological factors need to be considered when treating bifurcation lesions. To achieve optimal results, various stenting techniques have been developed, each with benefits and limitations. In this state-of-the-art review we describe technically important characteristics of bifurcation lesions and summarise the evidence supporting contemporary bifurcation techniques.

Valve-in-Valve Transcatheter Aortic Valve Implantation for the Failing Surgical Perceval Bioprosthesis.

INTRODUCTION: The Perceval Valve has been increasingly used in Surgical Aortic Valve Replacement (SAVR) recently due to ease of implantation. However, we have seen some cases of relatively early haemodynamic failure of the Perceval valve and these patients may then present for valve-in-valve transcatheter aortic valve implantation (ViV-TAVI). Experience of ViV-TAVI in the Perceval valve is limited. METHODS: We report our experience of VIV-TAVI in four cases of early-failing Perceval valves, two with stenosis and two with regurgitation. We also review the literature with regard to ViV-TAVI for this indication. RESULTS: Four patients aged between 66 and 78 years presented with Perceval valve dysfunction an average of 4.6 years following SAVR. All cases underwent Heart Team discussion and a ViV-TAVI procedure was planned thereafter. Strategies to ensure crossing through the centre of the valve and not outside any portion of the frame were found to be essential. Three patients had self-expanding valves implanted and one had a balloon-expandable prosthesis. The average aortic valve area (AVA) improved from 0.8 cm2 pre-procedure to 1.5 cm2 post-procedure*. The mean gradient (MG) improved from 35.5 mmHg (range 19.7-53 mmHg) pre-procedure to 14.8 mmHg (range 7-30 mmHg) post-procedure. In one patient a MG of 30 mmHg persisted following valve deployment. There were no significant peri-procedural complications. CONCLUSIONS: ViV-TAVI is a useful option for failed Perceval prostheses and appears safe and effective in this small series. Crossing inside the whole frame of the Perceval valve is essential.

Balloon Seal Separation Leading to SAPIEN 3 Transcatheter Heart Valve Deployment Failure: Complications and Management.

We present two cases of failure of balloon inflation secondary to balloon separation from the delivery catheter when implanting the SAPIEN 3 transcatheter heart valve (Edwards Lifesciences, Irvine, CA, USA). Although very uncommon, this is a potentially disastrous complication of transcatheter intervention. Case 1 highlights the complexity of the problem when it occurs and subsequent complications. Case 2 highlights how to manage this issue successfully.

Management and Outcome of Acute Ischemic Stroke Complicating Transcatheter Aortic Valve Replacement.

BACKGROUND: Despite advances in transcatheter aortic valve replacement (TAVR), periprocedural acute ischemic stroke remains a concern. OBJECTIVES: The aims of this study were to investigate acute ischemic stroke complicating TAVR (AISCT) and to describe the indications and outcomes of interventions to treat AISCT. METHODS: An international multicenter registry was established focusing on AISCT within 30 days of TAVR. Stroke severity was assessed using the National Institutes of Health Stroke Scale. Primary outcomes were 1-year all-cause death and neurologic disability status at 90 days according to modified Rankin scale score. RESULTS: Of 16,615 TAVR procedures, 387 patients with AISCT were included (2.3%). Rates of 1-year death were 28.9%, 35.9%, and 77.5% in patients with mild, moderate, and severe stroke, respectively (P < 0.001). Although 348 patients were managed conservatively, 39 patients (10.1%) underwent neurointervention (NI) with either mechanical thrombectomy (n = 26) or thrombolytic therapy (n = 13). In a subanalysis excluding patients with mild stroke, there was no clear 1-year survival benefit for NI compared with conservative management (47.6% vs 41.1%, respectively; P = 0.78). In a logistic regression model controlling for stroke severity, NI was associated with 2.9-fold odds (95% CI: 1.2-7.0; P = 0.016) of independent survival at 90 days. CONCLUSIONS: AISCT carries significant morbidity and mortality, which is correlated with stroke severity. The present findings suggest that neurologic disability for patients with moderate or worse stroke could potentially be improved by timely intervention and highlight the importance of collaboration between cardiologists and neurologists to optimize AISCT outcomes.

Hemopneumothorax - An Unexpected Cath Lab Diagnosis.

A 57-year-old woman presented with chest pain. Electrocardiography (ECG) revealed an inferior ST-segment elevation myocardial infarction. Thrombolysis was initiated and repeat ECG showed reduction of ST elevation. The patient reported ongoing pain and developed hypotension. Fluoroscopy of the chest demonstrated gross tracheal deviation and collapse of the left lung. This case highlights the importance of maintaining a broad differential diagnosis and of harnessing the various skills within a multidisciplinary team.

Acurate Neo Implantation to Treat Degenerative Regurgitation of Surgical Bioprostheses.

Valve-in-valve transcatheter aortic valve replacement (VIV-TAVR) provides a safe and effective treatment option for failing surgical aortic bioprostheses. Self-expanding supra-annular valves offer optimal haemodynamics for this clinical application. The Acurate Neo transcatheter heart valve (THV) offers further unique advantages with stabilisation arches to assist with alignment, upper crowns to restrain bioprosthetic valve leaflets, rapid final opening coaxial to the left ventricular outflow tract and an open design that optimises future coronary access. We report our procedural technique and experience using the Acurate Neo THV in four VIV-TAVR implantations for patients aged between 70 and 81 yrs. All patients presented with severe symptomatic valvular aortic regurgitation (AR), one of whom was in cardiogenic shock. The patients had malfunctioning surgical bioprostheses (stented n = 3; stentless n = 1) ranging in size from 21 to 25 mm. The Acurate Neo THV was successfully implanted in all patients without any complications, residual AR, coronary compromise or need for permanent pacing. Length of stay was 2 to 7 days. Follow-up to 12 months revealed no adverse events. The Acurate Neo THV is an attractive self-expanding option for patients with AR due to degeneration of a surgical aortic valve bioprosthesis.

Procedural Mortality With Transcatheter Aortic Valve Replacement - Balloon Inflation is Associated With Increased Risk.

OBJECTIVES: To assess the impact of balloon use for predilation, valve implantation, or postdilation on in-hospital mortality among patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: TAVR utilizes self-expanding, mechanically expanding, or balloon-expandable valves. Balloon inflation is inherent to deployment of balloon-expandable valves. Balloons may additionally be used with all valve types for pre- and postdilation. The relationships between valve mechanism, balloon use, and in-hospital mortality are not fully characterized. METHODS: Prospective data were collected on 4063 patients undergoing TAVR for aortic stenosis at 4 high-volume centers in the United Kingdom. In-hospital mortality was analyzed according to valve expansion mechanism, use of balloons for pre- and postdilation, and specific cause of death. RESULTS: Mean patient age was 83 ± 8 years. Implanted valves were self expanding (n = 2241; 55%), mechanically expanding (n = 1092; 27%), or balloon expandable (n = 727; 18%). In-hospital death occurred in 66 cases (1.6%). Thirty-six deaths (54.5%) were classified as implantation-related mortalities, with rates of 0.8%, 0.5%, and 1.7% (P=.04) among self-expanding, mechanically expanding, and balloon-expandable technologies, respectively. Patients who underwent balloon inflation at any stage of their procedure (n = 2556; 63%) had significantly higher implantation-related mortality than those who did not (1.3% vs 0.3%, respectively; P<.01). Balloon-expandable valve procedures were associated with significantly higher all-cause mortality (2.6% vs 1.4%; P=.02) and implantation-related mortality (1.7% vs 0.7%; P=.02) than non-balloon-expandable valve procedures. Balloon-related complications accounted for 18 cases (26%) of total in-hospital mortality, including all 12 cases (17.4%) of annular rupture and 5 cases (7.2%) of coronary occlusion. CONCLUSIONS: Balloon use for predilation, valve implantation, or postdilation was associated with an increased mortality risk. Balloon-related complications were the largest contributor to in-hospital mortality, comprising all cases of annular rupture and the majority of coronary occlusion cases.

SMARTphone-based, early cardiac REHABilitation in patients with acute coronary syndromes: a randomized controlled trial.

BACKGROUND: There are well-documented treatment gaps in secondary prevention of coronary heart disease with a lack of clearly defined strategies to assist early physical activity after acute coronary syndromes (ACS). Smartphone technology may provide an innovative platform to close these gaps. OBJECTIVES: The primary goal of this study was to assess whether a smartphone-based, early cardiac rehabilitation program improved exercise capacity in patients with ACS. METHODS: A total of 206 patients with ACS across six tertiary Australian hospitals were included in this randomized controlled trial. Participants were randomized to usual care (UC; including referral to traditional cardiac rehabilitation), with or without an adjunctive smartphone-based cardiac rehabilitation program (S-CRP) upon hospital discharge. The primary endpoint was change in exercise capacity, measured by the change in 6-minute walk test distance at 8 weeks when compared to baseline, between groups. Secondary endpoints included uptake and adherence to cardiac rehabilitation, changes in cardiac risk factors, psychological well-being and quality of life status. RESULTS: Of the 168 patients with complete follow-up (age 56 ± 10 years; 16% females), 83 were in the S-CRP. At 8-week follow-up, the S-CRP group had a clinically significant improvement in 6-minute walk test distance (Δ117 ± 76 vs. Δ91 ± 110 m; P = 0.02). Patients in the S-CRP were more likely to participate (87% vs. 51%, P < 0.001) and adhere (72% vs. 22%, P < 0.001) to a cardiac rehabilitation program. Compared to UC, patients receiving S-CRP had similar smoking cessation rates, LDL-cholesterol levels, blood pressure reduction, depression, anxiety and quality of life measures (all P = NS). CONCLUSION: In patients with ACS, a S-CRP, as an adjunct to UC improved exercise capacity at 8 weeks in addition to participation and adherence to cardiac rehabilitation (Australian New Zealand Clinical Trials Registry; ACTRN12616000426482).