Predictors of Cerebral Embolic Debris During Transcatheter Aortic Valve Replacement: The SafePass 2 First-in-Human Study.

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 µm and >500 µm 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 µm and 14.0 particles >500 µm. 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 µm (p = 0.0259) and its presence on admission was associated with 4.1 times more particles >150 µm (p = 0.0130) and 8.1 times more particles >500 µm (p = 0.0086). Self-expanding valves were associated with twice the number of particles >150 µm (p = 0.0281). TASK score was positively correlated with number of particles >500 µm (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.

Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients: Final 2-Year Results From Onyx ONE.

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 P2Y12 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).

Dependence on permanent pacemakers inserted after transcatheter aortic valve implantation: predictive factors in a ten-year retrospective analysis: Rates and predictors of pacemaker dependence after TAVI.

AIMS: The requirement for a permanent pacemaker (PPM) is an important sequela after transcatheter aortic valve implantation (TAVI). The aim of this analysis was to identify predictive factors for pacemaker dependence in PPM-insertions post-TAVI. METHODS AND RESULTS: A retrospective analysis of all PPM insertions done between January 2009 and December 2018 (n=1,373) identified 33 patients who received a PPM within one month of TAVI. Thirty-two had completed a PPM check at one year and were included in the final analyses. Of those who had PPM insertions after TAVI, 41% (13/32) were not PPM-dependent at one year. This cohort was predominantly European (94%) and over half were octogenerians (56%). Statistically significant associations with being PPM-dependent at one year include intraoperative PPM dependence (OR 5.714 [95% CI: 1.163-28.070]; p=0.032), third-degree heart block being the indication for PPM insertion (OR 8.533 [95% CI: 1.616-45.063]; p=0.012) and mean valve depth over 6.0 mm (OR 6.222 [95% CI: 1.200-32.273]; p=0.030). CONCLUSIONS: A significant number of patients are not dependent on the PPMs inserted after TAVI. Although small, our study suggests that those who are pacing-dependent intraoperatively, have a third-degree heart block as their PPM indication or have a mean valve depth of over 6.0 mm, are more likely to be pacing-dependent in the long term. Larger studies are required to draw more definitive conclusions.

Ischemic and bleeding outcomes in patients with versus without atrial fibrillation: analysis from the onyx one month dapt program

BACKGROUND The Onyx ONE and Onyx ONE CLEAR studies demonstrated favorable safety and effectiveness in patients at high bleeding risk (HBR) who were event-free 1 month following Resolute Onyx zotarolimus-eluting stent (ZES) implantation and were then treated with single antiplatelet therapy (SAPT) through to 1 year. The present analysis assessed outcomes in patients with versus without history of atrial fibrillation (AF) in whom oral anticoagulant (OAC) use is common. METHODS HBR patients who were event-free at 1 month were sepa rated into 2 groups according to history of AF. Clinical outcomes be tween 1 and 12 months were assessed. RESULTS Among 1,506 patients who were event-free at 1 month in whom treatment with SAPT was intended, 536 (35.6%) had a history of AF and 970 (64.4%) did not. The mean number of HBR criteria at enrollment was 1.7 for AF compared with 1.5 for non-AF patients (p < 0.001). AF patients were more likely to be men (73% vs. 65%; p » 0.001), were more likely to have had prior PCI (34% vs. 28%; p » 0.03) or CABG (16% vs. 11%; p » 0.003), and were more likely taking OACs (80.6% vs. 10.6%; p < 0.001). At 1 year, 89% of AF and non-AF patients were taking SAPT (p » 1.00), although 85.8% of AF patients and 12.4% of non-AF patients were taking OAC (p < 0.001). Ischemic event rates were similar between AF and non-AF groups: target lesion failure (8.5% vs. 7.9%), cardiac death (2.8% vs. 2.5%), myocardial infarction (4.7% vs. 4.9%), target lesion revascularization (2.8% vs. 3.6%), and definite/probable stent thrombosis (0.4% vs. 0.8%), all p > 0.05. BARC 2 to 5 (16.0% vs. 9.4%) bleeding events were higher for AF compared with non-AF patients (p < 0.001) driven by BARC 2 bleeding; BARC 3 to 5 events were similar (4.5% vs. 3.7%; p » 0.49). CONCLUSION After Resolute Onyx ZES implantation in HBR patients and intended treatment of SAPT after 1 month, despite differences in baseline characteristics, ischemic events were similar but moderate bleeding events were higher in patients with versus without a history of AF. Further studies are warranted to optimize management of AF patients post-stenting to minimize the bleeding.

Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk.

BACKGROUND: Polymer-free drug-coated stents provide superior clinical outcomes to bare-metal stents in patients at high bleeding risk who undergo percutaneous coronary intervention (PCI) and are treated with 1 month of dual antiplatelet therapy. Data on the use of polymer-based drug-eluting stents, as compared with polymer-free drug-coated stents, in such patients are limited. METHODS: In an international, randomized, single-blind trial, we compared polymer-based zotarolimus-eluting stents with polymer-free umirolimus-coated stents in patients at high bleeding risk. After PCI, patients were treated with 1 month of dual antiplatelet therapy, followed by single antiplatelet therapy. The primary outcome was a safety composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year. The principal secondary outcome was target-lesion failure, an effectiveness composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. Both outcomes were powered for noninferiority. RESULTS: A total of 1996 patients at high bleeding risk were randomly assigned in a 1:1 ratio to receive zotarolimus-eluting stents (1003 patients) or polymer-free drug-coated stents (993 patients). At 1 year, the primary outcome was observed in 169 of 988 patients (17.1%) in the zotarolimus-eluting stent group and in 164 of 969 (16.9%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% confidence interval [CI], 3.5; noninferiority margin, 4.1; P = 0.01 for noninferiority). The principal secondary outcome was observed in 174 patients (17.6%) in the zotarolimus-eluting stent group and in 169 (17.4%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% CI, 3.5; noninferiority margin, 4.4; P = 0.007 for noninferiority). CONCLUSIONS: Among patients at high bleeding risk who received 1 month of dual antiplatelet therapy after PCI, use of polymer-based zotarolimus-eluting stents was noninferior to use of polymer-free drug-coated stents with regard to safety and effectiveness composite outcomes. (Funded by Medtronic; ONYX ONE ClinicalTrials.gov number, NCT03344653.).

Safety and Feasibility of a Novel Active Fixation Temporary Pacing Lead

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.

Treatment of Symptomatic Severe Aortic Stenosis With a Novel Resheathable Supra-Annular Self-Expanding Transcatheter Aortic Valve System.

OBJECTIVES: The purpose of this study was to prospectively evaluate the safety and clinical performance of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system (Medtronic, Inc., Minneapolis, Minnesota) in a single-arm, multicenter pivotal study in high- or extreme-risk patients with symptomatic aortic valve stenosis. BACKGROUND: Although outcomes following TAVR are improving, challenges still exist. The repositionable 14-F equivalent CoreValve Evolut R TAVR system was developed to mitigate some of these challenges. METHODS: Suitable patients (n = 60) underwent TAVR with a 26- or 29-mm Evolut R valve. Primary safety endpoints were mortality and stroke at 30 days. Primary clinical performance endpoints were device success per the VARC-2 (Valve Academic Research Consortium-2) and the percent of patients with mild or less aortic regurgitation 24 h to 7 days post-procedure. RESULTS: Patients (66.7% female; mean age 82.8 ± 6.1 years; Society of Thoracic Surgeons Score 7.0 ± 3.7%) underwent TAVR via the transfemoral route in 98.3%, using a 29-mm valve in 68.3% of patients. All attempts at repositioning were successful. No death or stroke was observed up to 30 days. The VARC-2 overall device success rate was 78.6%. Paravalvular regurgitation post TAVR was mild or less in 96.6%, moderate in 3.4%, and severe in 0% at 30 days. Major vascular complications occurred in 8.3%, and permanent pacemaker implantation was required in 11.7% of patients. CONCLUSIONS: The repositionable 14-F equivalent Evolut R TAVR system is safe and effective at treating high-risk symptomatic aortic stenosis patients. Repositioning was successful when required in all patients, with low rates of moderate or severe paravalvular aortic regurgitation and low permanent pacemaker implantation. (The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study; NCT01876420).

Position statement for the operator and institutional requirements for a transcatheter aortic valve implantation (TAVI) program.

The Cardiac Society of Australia and New Zealand (CSANZ) and the Australia and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) have joined together to provide recommendations for institutions and individual operators to assess their ability to initiate and maintain a transcatheter valve program. Transcatheter aortic valve replacement has been developed as an alternative to traditional surgical replacement of the aortic valve in high risk patients, particularly the frail elderly. The position paper has endorsed the important role of a multi-disciplinary "Heart Team" in selecting patients for TAVI as fundamental to the establishment of a successful program. The paper outlines recommendations for the cardiologist to have a background in structural intervention and the surgeon to have experience in high-risk aortic valve replacement. It is further recommended that TAVI programs be established in high volume cardiac surgical centres where on site valve surgery is performed. The paper is intended to provide guidance to individual operators and prospective institutions considering the establishment of a successful TAVI program.

Mid-term outcomes in patients following transcatheter aortic valve implantation in the CoreValve Australia and New Zealand Study.

BACKGROUND: Although numerous studies have reported the safety and effectiveness of transcatheter aortic valve implantation (TAVI), integration of this therapy into standard of care varies widely by region. We evaluated mid-term follow-up in 540 patients with severe symptomatic AS at high risk of surgical AV replacement, enrolled in the ongoing Medtronic CoreValve Australia-New Zealand Study. METHODS: Between August 2008 and July 2013, 10 centres in Australia/New Zealand enrolled 540 patients, which includes initial use of the CoreValve System for all investigators. Patients were deemed suitable for TAVI based on consensus of a multidisciplinary Heart Team. Primary endpoints were cardiovascular death and major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days. Data were fully monitored, and an independent Clinical Events Committee employed. RESULTS: Baseline characteristics include; 45% female, mean age 84 years, EuroSCORE 17.3±10.7%, and 74.9% had New York Heart Association III/IV symptoms. At 30 days, all deaths were cardiovascular (4.1%); MACCE was 11.5%. At one and two years, all-cause mortality was 11.9% and 21.2%; cardiovascular mortality, 9.9% and 15.2%; and stroke, 8.2% and 10.1%, respectively. CONCLUSIONS: Early experience with the CoreValve System in a large cohort of fully-monitored patients was associated with good early- and mid-term safety outcomes.

Percutaneous repair of aortic puncture with Amplatzer closure device during attempted transseptal puncture.

Attempted atrial transseptal puncture in a 63-year-old man undergoing an ablative procedure for atrial fibrillation was complicated by inadvertent delivery of an 8 Fr sheath across the aorta. Due to obesity-related perioperative risks, we opted for percutaneous repair rather than open-heart corrective surgery. Our case is unique for the novel percutaneous delivery of an Amplatzer atrial septal defect (ASD) closure device to the defect in the non-coronary aortic cusp through an 8 Fr left atrial multipurpose sheath not designed for this purpose. At 9-month follow-up, he had a mild residual internuclear ophthalmoplegia.

The incidence of transcatheter aortic valve implantation-related heart block in self-expandable Medtronic CoreValve and balloon-expandable Edwards valves.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has been performed at Waikato Hospital for high-risk severe symptomatic aortic stenosis patients who are considered unsuitable for conventional cardiac surgery for the last 3 years. The Medtronic CoreValve (MCV) is a self-expandable device, while the Edwards SAPIEN valve (EV) requires the use of a balloon to expand the device. This observational study reports and compares the incidence of heart block in both Medtronic and Edwards transcatheter valves. METHODS: All patients who underwent TAVI between the periods of 28 August 2008 and 27 July 2011 were included in this study. Preprocedure and daily postprocedure until discharge electrocardiograms (ECG) were obtained prospectively. New onsets of significant atrioventricular (AV) and bundle branch blocks were recorded. Patients with existing pacemaker and those who did not survive the procedure were excluded. RESULTS: Sixty patients underwent TAVI during the study period, of whom 40 (67%) and 20 (33%) patients had MCV and EV implanted, respectively. Seven patients were excluded from the analysis; 38 MCV and 15 EV patients fulfilled the criteria for analysis. Mean age was 80 ± 7 years, 57% were male. Five patients (9%) required permanent pacemaker (PPM) implantation, which occurred exclusively post MCV TAVI (MCV vs EV: 13% vs 0%, respectively; P=.02). The indications of PPM were complete heart block in 3 patients (60%), Mobitz II second-degree heart block in 1 patient (20%), and symptomatic sick sinus syndrome in 1 patient (20%). The incidence of left bundle branch block (LBBB) was increased after the TAVI procedure and was more significant with MCV implants (MCV vs EV: 42% vs 8%, respectively; P<.01). Of note, 2 of the 5 patients (40%) with pre-existing right bundle branch block (RBBB) who underwent TAVI required PPM (P=.01). CONCLUSION: MCV implantation is associated with a higher incidence of significant AV block requiring PPM implantation and LBBB compared to EV. The overall rate of PPM requirement post MCV TAVI is, however, lower than previously published data. Pre-existing RBBB may help in predicting the likelihood of developing significant AV block.

Outcomes of patients with untreated severe aortic stenosis in real-world practice.

BACKGROUND: Surgical aortic valve replacement remains the gold standard of the treatment of severe symptomatic aortic stenosis but is often not considered due to excessive risk factors and comorbidities especially in elderly patients. We describe the burden of untreated severe aortic stenosis at a tertiary care hospital in New Zealand. METHOD: Consecutive patients with severe aortic stenosis presented between January-December, 2005 were studied retrospectively. Outcome assessment included mortality, hospital stay and on going symptoms (angina >CCS class II, dyspnoea >NYHA class II and syncope). RESULTS: A total of 105 patients with severe aortic stenosis were identified (mean age 76 plus or minus 13 years, 51% men). Patients were divided into 3 groups according to the management strategy. (Group 1: Not referred for surgery as asymptomatic (n=25), Group 2: Declined for surgery (n=41), Group 3: Accepted for surgery (n=39)). Median follow-up was 34 months (interquartile range: 16-36 months). All-cause mortality in Group 1, Group 2 and Group 3 were 36%, 73% and 18% respectively while hospital days per 100 patient-years were 3.5, 10.1 and 6.4 and symptoms on last follow-up were 0%, 64% and 0% respectively. Almost half of symptomatic patients (Group 2 versus 3) were denied valve surgery due to comorbidities. Symptomatic patients had a significant mortality (p<0.0001) benefit with less hospitalisations (p<0.0001) post surgery. CONCLUSIONS: Untreated symptomatic severe aortic stenosis is associated with a poor prognosis and significant morbidity. For symptomatic patients with severe aortic stenosis who are denied surgery, alternative therapies such as transcatheter aortic valve implantation could be a viable option.

Complete heart block in late presentation of inferior STEMI successfully treated with percutaneous coronary intervention.

A 55-year-old female presented with 4-day history of fatigue and exertional shortness of breath. A late presentation inferior ST elevation myocardial infarction (STEMI) was diagnosed based on ST elevation in the inferior leads of electrocardiography and elevated cardiac troponin T (TnT). She developed complete heart block 1 day after admission to the hospital and remained hemodynamically stable. She was taken to the catheterization laboratory for a temporary pacing wire insertion. Coronary angiogram at the same time showed an occluded right coronary artery at the mid-section. The lesion was successfully opened. Within 24 hours, the patient's heart rhythm returned to sinus with first-degree atrioventricular block (AVB), thus avoiding the need for a permanent pacemaker. Current guidelines recommend medical management for late presentation hemodynamically stable STEMI of more than 72 H onset. Current ACC/AHA/HRS Pacemaker Guidelines recommend reperfusion strategy for acute presentation inferior STEMI associated with AVB. However, no clear strategy exists in the case of late presentation inferior STEMI with advanced AVB. Our case report suggests that late coronary intervention could be a management strategy in such a scenario in order to avoid a permanent pacemaker.

Post-transcoronary ethanol septal ablation (TESA) infective endocarditis complicated by a ventricular septal defect.

A 52-year-old man was referred to the cardiology outpatient service with exertional angina and shortness of breath due to hypertrophic obstructive cardiomyopathy. He underwent transcoronary ethanol septal ablation (TESA) with successful procedural outcome. The patient returned to hospital with a 3-week history of intermittent fever and a positive blood culture showing Staphylococcus aureus, sensitive to flucloxacillin. Transoesophageal echocardiography on admission demonstrated vegetation on interventricular septum and a repeated scan 10 days later demonstrated Doppler flow across the interventricular septum, confirming the presence of a small ventricular septal defect. This patient was successfully managed with 6 weeks of intravenous antibiotics and remained well at 1-year follow-up.

Transcatheter aortic valve implantation complicated by acute structural valve failure requiring immediate valve in valve implantation.

The first percutaneous transcatheter aortic valve implantation (TAVI) was performed in 2002 by Alain Cribier with over 10,000 valve implants since. Despite this, as with all new technologies we remain on a learning curve and continue to encounter new challenges and complications. We report a case of acute structural valve failure treated successfully with a second valve in valve implantation of transcatheter aortic valve in a patient who had severe aortic stenosis (AS) complicated by a severely unfolded aorta.