A 77-year-old man with a history of a Bentall procedure presented with acute decompensated heart failure. Investigations revealed severe bioprosthetic aortic valve regurgitation and a large pseudoaneurysm eroding the sternum. We describe the multimodal imaging and heart team planning to stent the pseudoaneurysm with an endograft followed by transcatheter valve-in-valve implantation.

Coarctation of aorta (CoA) in adults is often diagnosed incidentally during the work-up for secondary or resistant hypertension causes, making it one of the treatable causes of hypertension. Treatment options range from surgery to transcatheter interventions. We present 2 cases of complex coarctation anatomy managed successfully with a transcatheter approach, facilitated by meticulous planning using advanced imaging techniques. The first case had long-segment CoA, which required deployment of a custom-made 120-mm-long Cheatham platinum stent. The second case had coarctation associated with a hypoplastic arch and left subclavian ostial stenosis, which was managed with a combination of covered and uncovered stent. Both patients showed good postprocedural outcomes, which were confirmed by means of 3-month follow-up computed tomography demonstrating well expanded stents, no endoleak, complete exclusion of aneurysms, and well perfused great vessels.

Transcatheter aortic valve replacement (TAVR) generates significant debris, and strategies to mitigate cerebral embolization are needed. The novel Emboliner embolic protection catheter (Emboline, Inc., Santa Cruz, California) is designed to capture all particles generated during TAVR. This first-in-human study sought to assess the safety and feasibility of the device and to characterize the distribution and histopathology of the debris generated during TAVR. The SafePass 2 study was a prospective, nonrandomized, multicenter, single-arm investigation of the Emboliner device. Primary end points included 30-day major adverse cardiac and cerebrovascular events (MACCE) and technical performance. Computed tomography angiography was analyzed by an independent core laboratory, and filters were sent for histopathology of captured debris. Predictors of particle number were identified using >150 p.m and >500 p.m size thresholds. Of 31 subjects enrolled, technical success was 100%, and 30-day MACCE was 6.5% (2 cerebrovascular accidents, with 1 attributed to subtherapeutic dosing of rivaroxaban along with atrial fibrillation and the other to possible previous small ischemic strokes on magnetic resonance imaging; neither MACCE event had a causal relation to the Emboliner). All filters contained debris, with a median of 191.0 particles >150 p.m and 14.0 particles >500 p.m. Histopathology revealed mostly acute thrombus and valve or arterial tissue with lesser amounts of calcified tissue. A history of atrial fibrillation predicted a greater number of particles >500 p.m (p = 0.0259) and its presence on admission was associated with 4.1 times more particles >150 p.m (p = 0.0130) and 8.1 times more particles >500 p.m (p = 0.0086). Self-expanding valves were associated with twice the number of particles >150 p.m (p = 0.0281). TASK score was positively correlated with number of particles >500 p.m (p = 0.0337). The Emboliner device was safe and feasible. Emboli after TAVR appear more numerous than previously documented. Atrial fibrillation, higher TASK score, and self-expanding valve use conferred higher embolic burden. Notably, none of the tested computed tomography angiography features were able to identify with higher embolic risk. Larger-scale studies are needed to identify high-risk patients for selective embolic protection device use. (c) 2023 Elsevier Inc. All rights reserved. (Am J Cardiol 2023;207:28-34)

The authors declare no funding or conflict of interest for this article. The peer review history for this article is available at https://publons.com/publon/10.1111/nan.12896. Data sharing is not applicable to this article as no new data were created or analysed in this study.

BACKGROUND Resolute Onyx polymer-based zotarolimus-eluting stents (ZES) were noninferior in safety and effectiveness to BioFreedom polymer-free biolimus A9-coated stents (DCS) in high-bleeding-risk (HBR) patients treated with 1-month dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) at 1 year. OBJECTIVES This study reports the final 2-year results of the randomized Onyx ONE trial. METHODS The Onyx ONE (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients) trial randomly assigned HBR patients to treatment with ZES or DCS. Following 1-month DAPT, event-free patients received SAPT (either aspirin or a P2Y(12) inhibitor at physician discretion). The primary safety endpoint, a composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year, was determined at 1 year. Rates of primary and secondary endpoints were calculated after final follow-up at 2 years. RESULTS A total of 1,003 patients were randomly allocated to ZES and 993 patients to DCS. Follow-up was complete in 980 (97.7%) ZES patients and 962 (96.9%) DCS patients at 2 years. The primary safety endpoint occurred in 208 (21.2%) patients in the ZES group and 199 (20.7%) patients in the DCS group (risk difference: 0.5%; 95% CI: -3.1% to 4.2%; P = 0.78) at 2 years without significant differences in individual components of the composite endpoint. The secondary effectiveness endpoint occurred in 217 (22.1%) patients in the ZES group and 202 (21.0%) patients in the DCS group (risk difference: 1.1%; 95% CI: -2.5% to 4.8%; P = 0.54). CONCLUSIONS Among patients at HBR treated with 1-month DAPT followed by SAPT, the Resolute Onyx polymer-based ZES had similar 2-year outcomes for the primary safety and secondary effectiveness endpoint compared with the BioFreedom polymer-free DCS. (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy [DAPT] for High-Bleeding Risk Patients [Onyx ONE]; NCT03344653) (C) 2022 by the American College of Cardiology Foundation.

Purpose: To assess whether body mass index (BMI) is a prognostic indicator of adverse outcomes following transcatheter aortic valve implantation (TAVI).

Inpatient LV assessment post ACS is a recommended practice in most guidelines. In a busy hospital, performing an inpatient echocardiography may delay patient discharge. Aim:1)Does awaiting inpatient echocardiography in NSTE-ACS patients have any impact on discharge timing?2)When LV assessment is planned as an outpatient or not performed at all does it have an adverse outcome? Method: Patients admitted with NSTEACS over a 6month period to Waikato hospital were included. There were 3 cohorts: inpatient LV assessment, planned outpatient LV assessment and no LV assessment post index admission. Data was collected from ACSQI website and electronic hospital database Results: Of 297 patents admitted with ACS 182 were identified as NSTEACS. The mean follow-up was 238 days, which was similar in all 3 cohorts. Out of 119 patients who had inpatients LV assessment 3.3% (4pts) encountered a delayed discharge. 11% were readmitted with a cardiac event. Planned out patient echocardiography was done only in 14% at the recommended time frame of 3 months in whom no cardiac events were noted. 21%(3 of 14) of patients who were waiting outpatient echocardiography had a cardiac event needing readmission. Out of 63 patients with no LV assessment planned at discharge 35% (17pt) suffered a cardiac event. In spite of high readmission rates, <2% were admitted due to heart failure which might have been altered by a LV assessment. Conclusion: It appears readmission due to cardiac events post NSTEACS is reduced by a timely LV assessment without significant delays in discharge. However from this study it is uncertain performing a LV assessment could have prevented these readmissions.

The aim of this study is to demonstrate the feasibility of use of a new self-expanding transcatheter heart valve with unique locator technology which anatomically aligns and ‘clips’ the bioprosthesis over the native aortic valve with resultant minimal paravalvular leak and a low transvalvular

OBJECTIVE:This first-in-human study evaluated the safety and technical feasibility of the Tempo temporary cardiac pacing lead (BioTrace Medical), which includes a novel fixation mechanism and soft tip.BACKGROUND:Complications of temporary pacing leads include dislodgment, arrhythmias, and ventricular perforation. Temporary pacing applications have increased with transcatheter aortic valve replacement (TAVR) growth, for rapid pacing during balloon valvuloplasty (BAV) and valve deployment, and for periprocedural bradyarrhythmia support.METHODS:Eligible patients required temporary pacing for TAVR, BAV, or electrophysiology (EP) procedures. Transthoracic echocardiograms were obtained at baseline and 24 hours after lead removal. Safety was defined as freedom from pericardial effusion requiring intervention or evidence of tamponade. Technical feasibility involved successful intracardiac delivery and pace capture. Additional evaluations included pacing threshold (PCT), rapid pacing, dislodgment, or sustained ventricular arrhythmias. Follow-up was to 30 days.RESULTS:Twenty-five patients (60% female; mean age, 64 ± 19 years) underwent 13 TAVRs (7 Sapien 3 valves [Edwards Lifesciences], 4 CoreValves [Medtronic], and 2 Lotus valves [Boston Scientific]), 11 EP procedures, and 1 BAV at two New Zealand centers from January 2016 to June 2016. Safety was met in all patients, with no device-related adverse events. Technical feasibility was achieved in 23 cases (92%); 2 patients had unsuitable anatomy. No patient had lead dislodgment or sustained ventricular arrhythmias, and the final procedural PCT was 0.7 ± 0.5 mA. Rapid pacing was successful in all cases. Five patients had successful postprocedural use up to 5 days.CONCLUSION:This first-in-human study demonstrates the safety and technical feasibility of the Tempo lead, providing stable periprocedural temporary pacing support.

Introduction: The association of patent foramen ovale (PFO) and migraine remains unclear. Aim: To determine the long-term effect of percutaneous closure of patent foramen ovale (PFO) defects on the incidence and frequency of migraine. Methods: This was a retrospective telephone survey in consecutive patients who underwent percutaneous PFO closure at Waikato hospital. The frequency of migraine before and after PFO closure was noted. Results: 53 procedures were done on 50 patients. Indication for PFO closure was stroke (94%), peripheral embolisation (2%), barotrauma (2%) and postoperative desaturation (2%). 56% patients were male and average age was 46 years. 98% of patients had a successful PFO closure with 6% closed at the second attempt and 1(2%) closed surgically. In 1 patient PFO was purposefully left unclosed. Bubble study at 6 months was done in 92% of patients. In 87% of patients complete closure were observed. There were no device migration, erosion or thrombus noted. At the follow-up period of 1337 ± 785days, 47 patients had telephone interview. 14 (30%) patients had an incidental history of migraine before the PFO closure. 50% reported a complete resolution of migraine with 1 new onset migraine post PFO closure. 87% reported a reduction of migraine episodes per week after PFO closure (P = 0.04).Tabled 1Before PFO closureAfter PFO closurePMigraine n (%)14 (30%)8 (17%)0.22Average Migraine episodes per week4560.04 Open table in a new tab Conclusion: Closure of PFO shows a strong association with reduction in migraine frequency.

Background: Poor LV function is an important prognostic factor in all forms of heart disease. Severe AS patients with LVEF≤35% are at high risk for aortic valve intervention. We assessed the effect of balloon aortic valvuloplasty (BAV) in predicting LV reserve in this cohort. Methods: All BAV patients at Waikato Hospital were prospectively collected. Patients with severe LV impairment (EF≤35%) were compared to those without. The change in LV function following BAV was assessed. Results: 349 patients underwent BAV over a 9-year period. 23% (81 patients) had LVEF≤35% pre BAV. Overall 30-day MACE rate was 5.7% with no significant difference between the groups. There was no difference in age with more males (73% vs. 58%, p = 0.02) in the low EF group. This cohort also had more MR≥2 (52% vs. 35%, p = 0.01) and higher PA pressure (51.7 vs. 43.0 mmHg, p = 0.0008) recordings. Their aortic mean gradients (AMG) were lower (39.4 vs. 50.4 mmHg, p < 0.0001) with lower derived aortic valve area (0.6 cm2 vs. 0.7cm2, p = 0.02) 8 patients (2%) were excluded from post BAV comparison due to death or inadequate data. Post BAV in the low EF group 51% showed improvement in LVEF>35% (p < 0.0001) indicating an adequate LV reserve. Similar effects were seen in a sub cohort with low EF≤35% and low gradient (AMG < 40 mmHg). Conclusion: BAV can be safely performed in patients with low EF. In this cohort a significant proportion of patients showed improvement of LV function indicating reasonable LV reserve and presenting themselves as an attractive candidate for a future definitive treatment.

Background: Before the advent of transcatheter aortic valve implantation (TAVI), BAV was used to palliate symptoms in cases of severe aortic stenosis. BAV usage has increased recently through its application as bridge to surgical aortic valve replacement (B-SAVR) or TAVI (B-TAVI). The aim of this study was to evaluate the outcomes of BAV in a contemporary cohort. Methods: The outcomes of 107 consecutive patients who underwent BAV between 2009-2016 were analysed retrospectively on the basis of the indication; palliation, B-SAVR or B-TAVI. Results: From the time of BAV the median survival for palliative (n = 76), B-SAVR (n = 18) and B-TAVI (n = 13) patients differed significantly (718, 1324 and 2378 days respectively, p < 0.01). The 1-year MACE free survival for palliative, B-SAVR and B-TAVI also differed significantly (45%, 60% and 90% respectively, p < 0.01, logrank test). There were no in-hospital deaths, 30-day MACE occurred in 10 patients (9%) including vascular complications in 7 patients (6.5%). Left ventricular ejection fraction, age, mean peak gradient (pre- or post-BAV) and percentage drop in mean peak gradient were not independent predictors of outcome. Conclusion: The median survival for palliative BAV in our contemporary cohort (718 days) is significantly longer than published, historical data (315 days). Furthermore, when BAV is utilised as a bridge to definitive therapy survival outcomes are superior. For patients who require BAV, B-TAVI is a reasonable treatment pathway that is non-inferior to B-SAVR. In our cohort B-TAVI shows superior 1 year MACE-free survival despite similar baseline characteristics; given the small sample size, further investigation is required before generalisation to the wider population.

Introduction: Patent foramen ovale (PFO) has been closed for multiple indications. Evidence to support these indications is continuing to mount. Aim: To evaluate the safety and effectiveness of percutaneous PFO closure at Waikato Hospital. Methods: All information regarding the PFO closure including a six-month bubble study was gathered prospectively. The longer-term outcome was assessed by a telephone interview. Results: 53 procedures were done on 50 patients. Indication for PFO closure was stroke (94%), peripheral embolisation (2%), barotrauma (2%) and postoperative desaturation (2%). Mean age was 45 years. Average waiting time for procedure was 76 ± 70days. Multiple devices were used to close the PFO (Amplatzer (60%), Primer (8%), Coherex (12%) and Occlutech (20%)). 58% PFO was closed using transoesophageal echo, 30%with intracardiac echo and no ultrasound imaging in 12%. 98% of patients had a successful PFO closure with 6% closed at the second attempt and 1(2%) closed surgically. In 1 patient PFO was purposefully left unclosed. There was no perioperative vascular complication, Major bleed or stroke. 92% had a bubble study at 6 months 87% had complete closure with 9% showing <5 bubbles crossing. During follow-up (3.7 ± 2.2 years), one non-device related death was observed. There were no strokes and 2(4%) patients had a TIA. There was no new onset AF, device migration, erosion or thrombus noted during the follow-up. 94% of patients were on no anticoagulants at the time of follow-up. Conclusion: PFO closure has been performed effectively with no short- or long-term adverse events. The recurrences of neurological events during follow-up are very low.

Main Objective: To compare the continuity equation based AVA derived by using two-dimension LVOT diameter measurement from transthoracic echocardiogram (2DTTE), biplane average LVOT diameter based on MDCT against MDCT guided planimetry based LVOT area (reference standard). Hypothesis: LVOT is a non-circular structure. We believe a 3D assessment of LVOT area is likely to be truly representative of its area compared to a 2D assessment. Method: Retrospective single centre study of forty patients with severe aortic stenosis (AVA < 1.0 cm2) referred for trans catheter aortic valve implantation(TAVI). The AVA was calculated using the continuity equation. Results:Tabled 1TTE SP(Single plane)MDCTBP(Biplane)MDCTP(Planimetry)TTESP vs MDCTPP-valueMDCTBP vs MDCTPP-valueMean AVA (cm2)0.78 ± 0.210.95 ± 0.300.95 ± 0.300.0040.968Mean AVA index(cm2/BSAm2)0.42 ± 0.120.50 ± 0.170.50 ± 0.160.0070.980Mean LVOT area (cm2)3.8 ± 0.804.78 ± 1.394.81 ± 1.450.0010.917 Open table in a new tab Tabled 1Pearson Correlation CoefficientCorrelation (r)P valueTTE AVASP vs MDCT AVAP0.70<0.001MDCT AVABP vs MDCTAVAP0.96<0.001 Open table in a new tab Bland-Altman Analysis shows better agreement between MDCT AVABP and MDCT AVAP than that between TTE AVASP and MDCT AVAP. Conclusion: Our current measurement of LVOT in a single plane does not correctly represent the true area reflecting an error in the derived valve area. Measuring LVOT in more than one plane seems to better represent its true area. Using our current biplane technique on TTE to obtain LVOT area may better represent the true area and derive a more accurate aortic valve area.

Background: Complications with temporary pacing leads include dislodgement, causing loss of capture, ventricular perforation and arrhythmia. The use of temporary pacing has increased with the rapid evolution of transcatheter aortic valve replacement (TAVR), where dislodgement of the lead during or post procedure can have a serious adverse outcome. A novel pacing lead with active fixation and soft tip is designed to provide lead stability and minimise perforation. We report the first in human experience of the Tempo Lead (BioTrace Medical, San Carlos, CA). Methods: Patients were eligible for prospective study enrolment if they required temporary pacing for TAVR, balloon aortic valvuloplasty (BAV) or electrophysiology (EP) procedures. The lead was evaluated for safety (freedom from pericardial effusion requiring intervention and/or echocardiographic evidence of tamponade) and technical feasibility (intracardiac delivery, pace capture thresholds (PCT)). Successful rapid pacing, incidence of dislodgement and ventricular arrhythmias (>30 seconds) were recorded. Follow-up was to 30 days. Results: 25 patients at two New Zealand centres underwent 13 TAVR, 1 EP procedures and 1 BAV. The Tempo lead was successfully positioned in 23 cases (92%). The safety endpoint was met in all patients, with no device-related adverse events. Excellent PCT was maintained in all patients (0.7 ± 0.5 mA) with no loss of capture. Rapid pacing was successful in all patients. Five patients had long-term pacing (9hours to 5 days) with stable PCT (range 0.8-1.5mA). Conclusions: This first in human study demonstrates that the Tempo lead is safe and effective and provides stable peri- and post-procedural cardiac pacing.