Jude Medical Research Articles

Unique Tachycardia Recorded on a Cardiac Implantable Electronic Device: What is the Mechanism?

In a 55-year-old man with nonischemic cardiomyopathy, a unique tachycardia was recorded on a dual-chamber implantable cardioverter defibrillator (St. Jude Medical [Abbott]) as an automatic mode switch episode. This case report discusses the mechanism of tachycardia, how it can be differentiated from similar rhythms, and its clinical implications. The report explores device limitations in managing such tachycardias and presents reprograming strategies to prevent recurrence. This case emphasizes the importance of careful analysis of device-mediated arrhythmias and appropriate programming.

Passive Approximator Vascular Closure Device Use in Patients with Shallow Femoral Artery Depth Increases Puncture-site Complications in Neuroendovascular Treatment

Puncture-site complications in interventional radiology sometimes cause severe conditions. Vascular closure devices play an important role in preventing puncture-site complications. Vascular closure devices are divided into 2 types, the directly suturing or clipping type (active approximators) and adherent sealant types (passive approximators). However, which types of vascular closure device are the safest and most effective for achieving hemostasis remains unclear. We analyzed the efficacy of each type of vascular closure device and risk factors for puncture-site complications. This study investigated 327 consecutive cases of neuroendovascular surgery using a transfemoral procedure during a 2-year study period. Passive approximators (Angioseal [St Jude Medical, Saint Paul, MN] and Exoseal [Cordis Corporation, Miami, FL]) were mainly used in the first half and active approximators (Perclose [Abbot Vascular, Santa Clara, CA]) in the second. We compared groups and estimated risk factors for puncture-site complications. All procedures were successful. Comparing groups with and without puncture-site complications, use of passive approximators and ≥3 antithrombotic medications tended to be more frequent and distance from skin to femoral artery and body mass index tended to be lower in the group with complications without significance. The cutoff for femoral artery depth calculated from a receiver operating characteristic curve was 16.43 mm. Multivariate analysis revealed ≥3 antithrombotic medications (P= 0.002, OR 15.29, 95% CI 2.76-85.76) and passive approximator use in patients with femoral artery depth <16.43 mm (P < 0.001, OR 17.08, 95% CI 2.95-57.80) were significantly higher in the group with puncture-site complications. Passive approximator use in patients with shallow femoral artery depth increases puncture-site complications in neuroendovascular treatment.

Restricted cusp motion in newly implanted tricuspid bioprostheses: Incidence, predictors, and impact on survival

ObjectiveTo investigate the occurrence of restricted cusp motion (RCM) at the time of bioprosthetic tricuspid valve replacement (TVR) and analyze associated risk factors and outcomes. MethodsThis study involved adult patients who underwent TVR with a bioprosthesis at our institution between 2012 and 2022. Bioprosthetic cusp motion was analyzed de novo through a detailed review of intraoperative transesophageal echocardiograms (TEE). Two models of porcine valves were implanted: the Medtronic Hancock II bioprosthesis and the St Jude Medical Epic bioprosthesis. ResultsAmong the 476 patients who met the inclusion criteria, RCM was identified on immediate post-bypass TEE in 150 (31.5%); there was complete immobility of the cusp in 63 patients (13.2%) and limited movement of a cusp in 87 patients (18.3%). In a multivariable logistic regression analysis, the Hancock II model (odds ratio [OR], 6.15; P < .001), a larger orifice area (per IQR increase: OR, 1.58; P = .017), a smaller body surface area (per IQR increase: OR, .68; P = .040), and a lower ejection fraction (per IQR increase: OR, .60; P = .033) were independently associated with having RCM. Cox regression adjusting for 15 covariates revealed that RCM at the time of TVR was independently associated with an increased risk of mortality (hazard ratio, 1.35; P = .049). ConclusionsThis study revealed a high incidence of RCM in bioprosthetic valves in the tricuspid position detected shortly postimplantation, which was associated with increased late mortality. To reduce the probability of RCM, it is important to select the appropriate prosthesis model and size, particularly in small patients.

Thirty-year outcomes of low-intensity anticoagulation for mechanical aortic valve.

The long-term safety, efficacy, and outcomes of low-intensity anticoagulation for mechanical heart valves remain unclear. This study aimed to evaluate the long-term outcomes of low-intensity anticoagulation therapy after aortic valve replacement (AVR) with a mechanical prosthesis. This retrospective cohort study consulted medical records and conducted a questionnaire to investigate 519 patients who underwent single AVR with the St. Jude Medical bileaflet valve and were in sinus rhythm. All patients were followed up with an international normalized ratio (INR) target of 1.6-2.5, and their INR values were checked throughout the follow-up period. The survival rate, incidence of major adverse cardiac and cerebrovascular events (MACCE), and risk factors for cardiac death and MACCE were investigated. The total follow-up was 9793 patient-years, and the follow-up periods were 19.9 (standard deviation [SD]: 7.9) years. The mean INR was 2.03 (SD: 0.54). Survival rates from cardiac death were 93.6% in 20years and 85.2% in 30years. Advanced age ≥ 70years was the only significant risk factor for cardiac death and MACCE, and the INR < 2.0 was not significant risk factor for MACCE including thromboembolism or bleeding events. Low-intensity anticoagulation with an INR of 1.6-2.5 for patients with sinus rhythm after AVR with a bileaflet mechanical valve is safe and effective, even over 30years.

Same-day discharge after elective percutaneous closure of patent foramen ovale.

Percutaneous closure of the patent foramen ovale (PFO) is increasingly performed in specific patients with cryptogenic stroke or clinical evidence of a paradoxical embolism. This study was performed to determine the safety of same-day discharge (SDD) following such procedures. This is a prospective, observational study of patients undergoing elective percutaneous PFO closure in a single tertiary center in Portugal between January 2020 and July 2023. AmplatzerTM devices (St. Jude Medical, St. Paul, MN, USA) and NobblestichTM EL (HeartStitch, Inc., Fountain Valley, CA, USA) were used. After 6 months, the following events were looked at: post-procedural paroxysmal atrial fibrillation, stroke, unplanned cardiac re-hospitalization, urgent cardiac surgery, major vascular complications, pericardial effusions, device embolization, and death. We studied 122 consecutive patients (52% female, 68; 48±12 years old) who had elective percutaneous closure with success and no complications. Forty-nine (40%) had SDD. AmplatzerTM devices were used more frequently in the SDD group, while NobblestichTM EL was more common in the overnight group. During the overnight group's follow-up period, there was one non-cardiovascular death; there were no further events. SDD after elective percutaneous closure of PFO was shown to be a safe and successful patient management method, including NobblestichTM, which we describe for the first time. Our results prove the safety of this same-day discharge strategy. We hypothesize that in the near future, in selected cases, PFO closure might become an ambulatory procedure.

Comparison of the Early Results of Supra-Annular and Intra-Annular Aortic Valve Replacement in Isolated Aortic Valve Replacement.

This study aims to compare the early results of patients who underwent isolated aortic valve replacement (AVR) with supra-annular and intra-annular AVR. Between 2013 and 2019, 113 patients (77 males; mean age 57.8±16.36 years) who underwent isolated AVR were evaluated. The patients were divided into two groups those who underwent supra-annular (n=59) and intra-annular (n=54) AVR. The most commonly used valves in surgeries St Jude Medical Masters (St. Jude Medical, Minneapolis, MN, USA), (n=35, 30.9%), Sorin Mitroflow (Sorin Group Inc., Mitroflow Division, Canada), (n=32, 28.3%, and Carbomedics Top Hat (Sulzer, Carbomedics, Austin, TX), (n=31, 27.4%). The cross-clamp (XCL) and cardiopulmonary bypass (CPB) times of the patients who underwent supra-annular AVR were found to be significantly higher than the patients who underwent intra-annular AVR. However, there was no significant difference between the two groups in terms of postoperative adverse events. There was no significant difference between the two groups in the postoperative first-week transthoracic echocardiographic (TTE) findings. When comparing supra-annular and intra-annular valve positioning results in patients undergoing isolated AVR, no significant difference was found between the groups in terms of postoperative complications, gradient differences in postoperative TTE, and ejection fractions. Supra-annular valve positioning should be considered, especially in patients with small annulus, in the presence of suitable anatomical features. However, this issue needs to be investigated in future prospective studies with more patients.

PP18 Unlocking The Potential Of Medical Device Reimbursement In India For Better Health Outcomes

IntroductionThe Indian healthcare landscape has witnessed several promising changes including the introduction of a comprehensive medical technology inclusion process, Diagnosis-related group (DRG)-pilot and value-based incentives for hospital services under the national public health insurance scheme. Realizing the need for a more patient-centric stance towards improving healthcare outcomes as the way forward, we propose incremental changes including greater participation of public and private care-providers in topic prioritization and the appraisal committee. We also propose a unique evidence-driven approach using reimbursement as a lever for rewarding quality and innovation in medical technologies.MethodsWe developed two discussion guides to capture the ideas around deeper involvement of care-providers and patient societies, and introduction of value-based reimbursement for incentivizing high-quality implantable medical devices in India. The guides were prepared using secondary research and key informant interviews. Over 25 key stakeholders representing payers, regulatory agencies, government authorities, clinical experts, and industry players selected through quota sampling participated in a roundtable meeting. Based on the meeting outcomes, key recommendations for leveraging medical device reimbursement for better health outcomes were developed.ResultsThis qualitative research was carried out with participation of key stakeholders across the medical device reimbursement process. The group proposed recommendations for bringing care-providers closer to the process through a structured and inclusive nomination approach involving therapy users and patient groups at various stages of evaluation. Complementing the existing value-based incentives framework for hospital services, we proposed a similar two-step pathway for incentivizing quality of implantable medical devices. The proposal includes the introduction of certification-based and outcome-based incentives built on a scientific and holistic evaluation criterion.ConclusionsThrough this process, we created a pragmatic and concrete call for a stronger voice from care-providers and patient groups in the evaluation process. Consecutively, the proposed innovative framework introducing value-based incentives for implantable medical devices will be instrumental in enabling access to quality health care to poor patients. These strategies follow the principles of value-based care and will go a long way in achieving better health outcomes for the population. The scientific initiative has been made possible with the support of St. Jude Medical India Pvt Ltd. (now Abbott).

PP40 Structuring Unstructured Medical Device Reimbursement In India

IntroductionAs India makes rapid strides towards universal health coverage, focusing on medical device reimbursement is key to ensuring patient access to device-based technologies. The nascent medical device reimbursement process offers a promising opportunity for interventions driven by a diverse group of stakeholders. We conducted policy research to capture these diverse perspectives and highlight key elements to develop a structured framework for reimbursement.MethodsThis research was a two-part process, including secondary research with expert interviews followed by policy research using focus group discussions (FGDs) through an online workshop with key stakeholders. We developed a white paper proposing changes to the reimbursement pathway, based on a benchmarking study of global markets and interviews with experts in the field. As a next step, key changes proposed in the white paper were deliberated upon by three focus groups (six to eight participants). Group participants were selected by quota sampling and represented key stakeholders in the reimbursement process. A discussion guide was used to capture participants’ opinions and an addendum to the white paper was released highlighting small, actionable, and impactful changes to the reimbursement process.ResultsFGDs with key stakeholders highlighted the need to establish a more structured, inclusive, and transparent process. Accordingly, we proposed key recommendations to the medical device reimbursement process in India. A first change is the creation of an online submission portal allowing different healthcare stakeholders to submit new technologies for consideration through a streamlined pathway. Secondly, we proposed enhancing evaluation transparency by improving availability of publicly shared information on the evaluation process, metrics, and assessment timelines. We also suggested adoption of adaptive health technology assessments to leverage existing evidence for faster, efficient decision-making.ConclusionsThrough this process, we created a pragmatic and concrete call for a stronger voice from care-providers and patient groups in the evaluation process. Consecutively, the proposed innovative framework introducing value-based incentives for implantable medical devices will be instrumental in enabling access to quality health care for poor patients. These strategies follow the principles of value-based care and will go a long way in achieving better health outcomes for the population. The scientific initiative has been made possible with the support of St. Jude Medical India Pvt Ltd (now Abbott).

Valvular and ascending aortic hemodynamics of the On-X aortic valved conduit by same-day echocardiography and 4D flow MRI.

This study aims to assess whether the On-X aortic valved conduit better restores normal valvular and ascending aortic hemodynamics than other commonly used bileaflet mechanical valved conduit prostheses from St. Jude Medical and Carbomedics by using same-day transthoracic echocardiography (TTE) and 4D flow magnetic resonance imaging (MRI) examinations. TTE and 4D flow MRI were performed back-to-back in 10 patients with On-X, six patients with St. Jude (two) and Carbomedics (four) prostheses, and 36 healthy volunteers. TTE evaluated valvular hemodynamic parameters: transvalvular peak velocity (TPV), mean and peak transvalvular pressure gradient (TPG), and effective orifice area (EOA). 4D flow MRI evaluated the peak systolic 3D viscous energy loss rate (VELR) density and mean vorticity magnitude in the ascending aorta (AAo). While higher TPV and mean and peak TPG were recorded in all patients compared to healthy subjects, the values in On-X patients were closer to those in healthy subjects (TPV 1.9 ± 0.3 vs. 2.2 ± 0.3 vs. 1.2 ± 0.2 m/s, mean TPG 7.4 ± 1.9 vs. 9.2 ± 2.3 vs. 3.1 ± 0.9 mmHg, peak TPG 15.3 ± 5.2 vs. 18.9 ± 5.2 vs. 6.1 ± 1.8 mmHg, p < 0.001). Likewise, while higher VELR density and mean vorticity magnitude were recorded in all patients than in healthy subjects, the values in On-X patients were closer to those in healthy subjects (VELR: 50.6 ± 20.1 vs. 89.8 ± 35.2 vs. 21.4 ± 9.2 W/m3, p < 0.001) and vorticity (147.6 ± 30.0 vs. 191.2 ± 26.0 vs. 84.6 ± 20.5 s-1, p < 0.001). This study demonstrates that the On-X aortic valved conduit may produce less aberrant hemodynamics in the AAo while maintaining similar valvular hemodynamics to St. Jude Medical and Carbomedics alternatives.

Abstract 14927: Transcatheter Aortic Valve Implantation Bailout for Severe Aortic Insufficiency Due to Aortic Root Dissection Following Ascending Aortic Aneurysm Repair

Case Presentation: 75-year-old female with history of conservatively managed ascending aortic aneurysm with mild Aortic Insufficiency (AI) and a chronic Type B aortic dissection. Due to rapid aneurysmal expansion she underwent surgical ascending aortic aneurysm repair with a 32-mm Gelweave graft, aortic valve commissuroplasty, and 1-vessel aorta-to-right coronary artery bypass graft. She was discharged 15 days post-op in stable condition. However presented 2 weeks later with new onset dyspnea with minimal exertion, orthopnea, peripheral edema, wide arterial pulse pressure (150/50 mmHg), jugular venous distention. Transthoracic and transesophageal echocardiography showed a new and severe AI, with preserved left ventricular ejection fraction. A computed tomography angiogram (CTA) of the chest showed an acute aortic dissection at the proximal and distal segments of the aortic graft (Figure 1). She underwent a transcatheter aortic valve implantation (TAVI) with a self-expanding bioprosthesis: 27 mm Portico TM valve (St. Jude Medical, St. Paul, MN, USA) anchored at the annular level (annular area 370 mm 2 , perimeter 69 mm with calculated over sizing of 30%) and at the 32 mm Gelweave graft level (42 mm bioprosthesis aortic outflow dimension) without acute complications (Figure 2). She was discharged and remained clinically well without recent readmission for CHF exacerbation. Conclusions: Patient was deemed a poor surgical candidate due to frailty and recent sternotomy. This case demonstrates TAVI as off-label treatment option for severe AI due to aortic root dissection in poor surgical candidates.

Porcine or Bovine Tissue Valves: Which are Better for Surgical Aortic Valve Replacement?

Summary The choice between mechanical and bioprosthetic aortic valve implants is affected by relatively clear criteria. However, the choice between porcine or pericardial valve is more complex regarding bioprosthetic devices. We aimed to elucidate any hemodynamic and clinical difference between two widely used bioprosthetic valves: the Sorin Mitroflow bovine pericardial valve and the St. Jude Medical Epic Supra porcine valve. We retrospectively studied 71 consecutive patients separated into two groups based on the valve they received. Clinical outcomes included patient survival and hemodynamic performance of the implanted prostheses. Patients were assessed at one and five years postoperatively. Mean transprosthetic pressure gradients were used as a marker of hemodynamic performance. The Mitroflow valve exhibited lesser mean transvalvular gradients than the Epic valve for all labelled sizes at one and five years postoperatively. The 5-year survival was equal between groups. Both prostheses demonstrated a small but significant increase in mean pressure gradients in the fifth year. Most patients enjoyed significant clinical improvement as assessed by NYHA functional class. Both bioprostheses performed very well with excellent hemodynamic parameters. The pericardial valves are a safe and appropriate choice for surgical bioprosthetic aortic valve replacement.

Mechanical atrioventricular valve replacement in patients with single ventricle palliation.

Atrioventricular valve (AVV) replacements in patients with single-ventricle circulations pose significant surgical risks and are associated with high morbidity and mortality. From 1997 to 2021, 16 consecutive patients with functionally single-ventricle physiology underwent mechanical AVV replacement. Primary outcome was transplant-free survival. Secondary outcomes included major postoperative morbidity. The median age of AVV replacement was 2 years old (interquartile range 0.6-3.8 years). All AVV replacements were performed with a St. Jude Medical mechanical valve, median 24 mm (range, 19-31mm). Extracorporeal membrane oxygenation (ECMO) was required in 4 patients. Operative mortality was 38% (6/16). There were 2 late deaths and 3 transplants. Transplant-free survival was 50% at 1 year, 37.5% at 5 years, and 22% at 10 years. Transplant-free survival was higher for patients with preserved ventricular function (P = 0.01). Difference in transplant-free survival at 1 year was 75% vs 25%, at 5 years was 62.5% vs 12.5% and at 10 years was 57% vs 0%. Three (19%) patients had complete heart block requiring permanent pacemaker insertion. 6 of 13 patients (46%) patients reached Fontan completion (3 patients operated at/after Fontan). Significant bleeding events occurred in 8 patients (50%) with 3 patients suffering major cerebrovascular accidents. There were 6 events of valve thrombosis in 5 patients, resulting in 2 deaths and 2 heart transplants. Mechanical valve replacement carries significant morbidity and mortality risk. While it successfully salvages about half of patients with preserved ventricular function, careful consideration of alternative options should be made before embarking upon mechanical valve replacement.

Duo-decapolar catheter entrapment in the Chiari network: successful extraction with the snare catheter

BackgroundThe Chiari network (CN) is the net-like embryonic remnants of the right valve of the sinus venosus. Catheter entrapment by CN is a not uncommon complication during catheter manipulation inside the right atrium (RA).Case presentationA 49-year-old man with atrial fibrillation was admitted for cryoablation. Transesophageal echocardiography revealed a prominent CN in the RA. Through the sheath placed in the right femoral vein, a diagnostic electrophysiologic duo-decapolar (DD) catheter (Livewire, St Jude Medical, St Paul, MN) was advanced. The catheter tip was knotted after multiple rotations in the RA to properly locate the DD catheter at the RA wall and coronary sinus (CS). Initial attempts to disentangle the folded catheter tip by traction and rotation maneuvers were unsuccessful. We inserted the large-bore sheath (Sentrant; Medtronic, 20 Fr) into the patient’s left femoral vein and then, captured the folded catheter tip with the 20-mm circular snare catheter (Snare Kit, Medtronic, Minneapolis, MN). Then, we cut the proximal portion of the DD catheter externally and removed it retrogradely through the Flexcath sheath. We found that the catheter tip was entrapped by the fibrous tissue of the CN. After a successful retrieval, cryoablation was conducted as planned. Follow-up echocardiography did not reveal any peri-procedural complications.ConclusionsThe electrophysiological procedure that exists at the RA entails a potential risk of catheter entrapment manipulating the catheter at the RA. If catheter entrapment occurs during the procedure, the entrapped catheter may be removed via a large-bore sheath using a snare catheter.

Mid-term outcomes and hemodynamic performance of the St Jude Medical Epic aortic bioprosthesis for severe aortic stenosis.

The St. Jude Medical Epic Supra valve is a porcine bioprosthesis designed for complete supraannular implantation. No report has shown the hemodynamic performance and clinical outcomes of aortic valve replacement with the Epic Supra valve for severe aortic stenosis in a Japanese cohort. We retrospectively evaluated 65 patients who underwent aortic valve replacement using the Epic Supra valve for aortic stenosis at our department between May, 2011 and October, 2016. The mean follow-up period was 68.7 ± 32.7months, and the follow-up rate was 89.2%. The mean age was 76.8 ± 5.3years. The 1-, 5-, and 8-year survival rates were 96.9%, 79.4%, and 60.3%, respectively. The rates of freedom from valve-related events were 96.6% and 81.9% at 5 and 8years, respectively. Four patients were diagnosed with structural valve deterioration (SVD), and reintervention was performed in two patients. The rates of freedom from SVD were 98.2% and 83.3% at 5 and 8years, respectively, and the mean time to diagnosis of SVD was 72.5 ± 25.3months. The mean pressure gradient (MPG) was 16.8 ± 6.0mmHg postoperatively, 17.5 ± 9.4mmHg at 5years, and 21.2 ± 12.4mmHg at 8years (p = 0.08). The effective orifice area index (EOAI) was 0.95 ± 0.2 cm2/m2 immediately after surgery, 0.96 ± 0.27 cm2/m2 at 5years, and 0.84 ± 0.2 cm2/m2 at 8years (p = 0.10). An increase in MPG and decrease in EOAI were also observed, which may be associated with SVD. Follow-up after 5years is important to determine if there is an increase.

Successful management of the leaflet perforation after the transcatheter edge-to-edge repair procedure using transcatheter occlusion.

A 57-year-old female was diagnosed with chronic heart failure and severe functional mitral regurgitation (FMR) despite guideline-directed medical therapy. An echocardiogram revealed severe mitral regurgitation (MR) (4+) vena contracta width 8 mm with ejection fraction (21%), and no calcification on the annulus and leaflets was noted. Mitral transcatheter edge-to-edge repair (TEER) was attempted for this patient. Transcatheter edge-to-edge repair was done under general anaesthesia with transoesophageal echocardiography (TEE) guidance using a novel designed SQ-Krin TEER system (Shenqi Medical). After transseptal puncture was achieved, a 24F guiding sheath was placed in the left atrium (LA). Then, one LW-size clip (6 mm width with 12 mm arm length) was placed in the A2/P2 region (Panel A). Mitral regurgitation severity was reduced to none (Panel A). However, 20 min after release, TEE revealed a large regurgitant gap (7–8 mm) between the anterior mitral leaflet (AML) and the clip arm with torrential MR (Panels B–D), and clip-induced leaflet perforation was confirmed. Considering the high risk of open-heart surgery, transcatheter occlusion was attempted. A 14F steerable catheter was placed in the LA through the previous puncture site, and the guide wire was placed into the left ventricle (LV) through the tear hole, and then a 14 mm Amplatzer Vascular Plug II (St Jude Medical, Abbott) was implanted through the delivery system to occlude the hole (Panels E and F). Mitral regurgitation was reduced to a mild degree after the procedure (Panels G and H). Post-operative recovery was uneventful and no sign of haemolysis. In the 1-year follow-up, the patient presented good condition with mild MR, and both the clip and the plug were in a stable position (Panel I). Leaflet perforation after the TEER procedure is a rare complication with a poor prognosis, especially for an FMR patient. Other than open-heart surgery, transcatheter occlusion may provide a reliable salvage management option.

Amiodarone does not significantly affect the success rate of ventricular fibrillation induction tests performed during or after ICD implantation. Insights from the German DEVICE registry

Abstract Funding Acknowledgements Type of funding sources: Other. Main funding source(s): The DEVICE registries were financed by “Stiftung Institut für Herzinfarktforschung (IHF)”, with additional support by grants from Biotronik, Medtronic, and St. Jude Medical. Background Experimental data and early clinical trials suggested that amiodarone may alter the defibrillation threshold of ICD systems. However, because of its potent antiarrhythmic effect and lack of alternatives, amiodarone is frequently used for antiarrhythmic therapy in ICD or CRT-D patients, leading to the question of whether ICD testing with ventricular fibrillation induction should be repeated in these patients after starting amiodarone. Objective This study was designed to assess the impact of amiodarone therapy on the success of ventricular fibrillation induction tests in this "real life" cohort of ICD recipients of the German DEVICE registry. Methods 3,680 patients who underwent ICD implantation, revision, or upgrade in 49 centers participating in the German DEVICE Registry were enrolled 03/2007-02/2014. Results Intraoperative defibrillation testing was conducted in 2,705 patients receiving only beta-blockes as antiarrhythmic therapy and in 422 patients under betablocker plus amiodarone therapy. With regard to ineffective defibrillation tests, no difference could be described between the two groups (0.6% vs. 0.5%; p=0.77). In a similar fashion 488 patients receiving beta-blockers only and 65 patients under beta-blocker plus amiodarone therapy who were scheduled for postoperative defibrillation testing showed comparable rates of ineffective testing (14.5% vs. 15.4%; p=0.86). Conclusions Based on 3,127 intraoperative and 553 postoperative defibrillator testings, our study failed to show a significant association of amiodarone therapy and ineffective defibrillator testings in this "real life" cohort of ICD recipients of the German DEVICE registry. Our results thus underline that, apart from special situations such as right-sided implantation, HCM, extravenous ICD systems, etc., it might not be necessary to perform a DFT test after the start of an amiodarone therapy in ICD patients.

Ventricular tachycardia predicts all-cause mortality and non-sudden cardiac death in non-ischaemic cardiomyopathy

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): The DCM-VT study was partially supported by an investigator-initiated grant (IIS-310) from Biosense Webster (a Johnson &amp; Johnson company). The DANISH study was supported by unrestricted grants from Medtronic, St. Jude Medical, TrygFonden, and the Danish Heart Foundation. Background Endstage heart failure, ventricular tachycardia (VT) and sudden cardiac death (SCD) are sequels of non-ischaemic cardiomyopathies (NICM). Implantable cardioverter defibrillators (ICDs) can terminate VT and prevent SCD but mortality benefit has been limited in recent trials suggesting that VT may also be associated with non-sudden cardiovascular death (NSCVD). Purpose To assess the effect of VT on all-cause mortality and NSCVD in NICM patients with ICDs. Methods Two multicenter cohorts of NICM patients were merged for analysis: (1) patients randomized to ICD in the DANISH trial, which included patients with NICM, LVEF ≤35% and no prior VT and (2) the DCM-VT study cohort, which included consecutive NICM patients with any LVEF referred for ablation of sustained VT. Predictors for the primary composite outcome of all-cause death and heart transplant (death/HTx) and for the secondary outcome of NSCVD were assessed. In addition, propensity score matching was performed using the parameters age, gender, LVEF and eGFR. Finally, survival following VT occurrence was compared between DANISH and DCM-VT patients. Results A total of 828 patients (556 DANISH, 272 DCM-VT) were followed for a median of 3.9 years (2.1 – 5.8). DANISH patients had a median LVEF of 25% (20 – 30) and DCM-VT patients 35% (27 – 43). A total of 148 patients (DANISH 16.4%, DCM-VT 21.0%) experienced death/HTx and NSCVD occurred in 78 patients (7.7%, 12.9%, respectively). In multivariable analysis history of VT at inclusion was a significant predictor of the primary outcome with an adjusted hazard ratio (HRa) of 3.81 (95% CI 2.33 - 6.24) as were age [HRa 1.02 per year (1.01 - 1.04)], LVEF [HRa 0.96 per 1% increase (0.94 - 0.98)] and reduced eGFR [HRa 1.71 (1.15 – 2.53 )]. History of VT predicted NSCVD with an HRa of 7.54 (3.97 - 14.33). After matching, history of VT still predicted death/HTx [HR 4.12 (2.48 - 6.82)] and NSCVD [HR 6.92 (3.30 - 14.52)]. Risk of death/HTx, as well as NSCVD, for DANISH patients was similar to DCM-VT patients after they experienced their first VT event [HRa 0.90 (0.48 - 1.69) and HRa 1.07 (0.56 - 2.06) resp.]. Conclusions VT occurrence appears to be an important predictor of non-sudden CV death as well as all-cause death in NICM patients independent of other markers of heart failure severity. VT may be a marker of progressive disease and remodelling that could be incorporated into risk-stratification to help predict deterioration and need for HTx.

Capture threshold of bipolar and unipolar pacing of left ventricle via coronary sinus branch: longitudinal study.

The aim of this paper is to first monitor the changes in the capture threshold of endovascularly placed leads for left ventricle pacing, second to compare the pacing configurations, and third to verify the effect of Steroid elution for endovascular leads. The study included 202 consecutive single centre patients implanted with the Quartet™ lead (St. Jude Medical). The capture threshold and related lead parameters were tested during implantation, on the day of the patient's discharge, and 3, 9, and 15 months after implantation. The electrical energy corresponding to the threshold values for inducing ventricular contraction was recorded for subgroups of patients with bipolar and pseudo-unipolar pacing vectors and electrodes equipped with and without a slow-eluting steroids. The best setting for the resynchronization effect was generally chosen. Capture threshold was taken as a selection criterion only if there were multiple options with (expected) similar resynchronization effect. The measurements showed that the ratio of threshold energies of UNI vs. BI was 5× higher (p < 0.001) at implantation. At the end of the follow-up, it dropped to 2.6 (p = 0.012). The steroid effect in BI vectors was caused by a double capture threshold in the NSE group compared to the SE group (p < 0.001), increased by approximately 2.5 times (p < 0.001). The study concludes that after a larger initial increase in the capture threshold, the leads showed a gradual increase in the entire set. As a result, the bipolar threshold energies increase, and the pseudo-unipolar energies decrease. Since bipolar vectors require a significantly lower pacing energy, battery life of the implanted device would improve. When evaluating the steroid elution of bipolar vectors, we observe a significant positive effect of a gradual increase of the threshold energy.

Right Atrial Appendage Tachycardia: Ablation should be the First Approach?

A 64-year-old female patient with symptomatic premature atrial contraction (PAC) and atrial tachycardia (AT) referred for EPS (electrophysiologic study) and ablation. EPS and successful ablation were performed guided by a 3D activation mapping system NavX (St. Jude Medical, St. Paul, MN, USA) with complete resolution of symptoms and arrhythmia. Site of origin (SOO) was right atrial appendage (RAA).

Long-term valve performance of St Jude Medical Epic porcine bioprosthesis in aortic position.

The aim of this study was to review long-term clinical outcomes and valve performance after Epic Supra valve implantation in aortic position. From 2011 to 2022, 44 patients (mean age 75 ± 8years) underwent surgical aortic valve replacement (SAVR) with an Epic Supra valve at our hospital. Survival, incidence of late complications, and echocardiographic date were retrospectively analyzed. During a mean follow-up period of 6.2 ± 3.5years, the overall survival rate was 91 ± 4% at 2 and 88 ± 5% at 5years, while rates of freedom from major adverse cardiovascular and cerebrovascular events (MACCE) were 86 ± 5% and 83 ± 6%, respectively. There was one case of reoperation for prosthetic valve endocarditis at 6years after the initial surgery. Echocardiographic examinations showed 5-year rates of freedom from severe structural valve deterioration (SVD) and moderate SVD of 100 and 92%, respectively. There was no significant increase in mean pressure gradient or decrease in left ventricular ejection fraction from 1week after surgery to the late follow-up period. Long-term clinical results and durability of the Epic Supra valve in aortic position were satisfactory.