Contemporary trends of leadless pacemaker implantation in the United States.

INTRODUCTION: Leadless pacemakers (LPM) have established themselves as the important therapeutic modality in management of selected patients with symptomatic bradycardia. To determine real-world utilization and in-hospital outcomes of LPM implantation since its approval by the Food and Drug Administration in 2016. METHODS: For this retrospective cohort study, data were extracted from the National Inpatient Sample database from the years 2016-2020. The outcomes analyzed in our study included implantation trends of LPM over study years, mortality, major complications (defined as pericardial effusion requiring intervention, any vascular complication, or acute kidney injury), length of stay, and cost of hospitalization. Implantation trends of LPM were assessed using linear regression. Using years 2016-2017 as a reference, adjusted outcomes of mortality, major complications, prolonged length of stay (defined as >6 days), and increased hospitalization cost (defined as median cost >34 098$) were analyzed for subsequent years using a multivariable logistic regression model. RESULTS: There was a gradual increased trend of LPM implantation over our study years (3230 devices in years 2016-2017 to 11 815 devices in year 2020, p for trend <.01). The adjusted mortality improved significantly after LPM implantation in subsequent years compared to the reference years 2016-2017 (aOR for the year 2018: 0.61, 95% CI: 0.51-0.73; aOR for the year 2019: 0.49, 95% CI: 0.41-0.59; and aOR for the year 2020: 0.52, 95% CI: 0.44-0.62). No differences in adjusted rates of major complications were demonstrated over the subsequent years. The adjusted cost of hospitalization was higher for the years 2019 (aOR: 1.33, 95% CI: 1.22-1.46) and 2020 (aOR: 1.69, 95% CI: 1.55-1.84). CONCLUSION: The contemporary US practice has shown significantly increased implantation rates of LPM since its approval with reduced rates of inpatient mortality.

Infections and associated costs following cardiovascular implantable electronic device implantations: a nationwide cohort study.

Aims: This study assessed the contemporary occurrence of cardiac device infections (CDIs) following implantation in French hospitals and estimated associated costs. Methods and Results: A retrospective analysis was conducted on the French National Hospital Database (PMSI). Patients with a record of de novo cardiac implantable electronic device (CIED) implantation or replacement interventions in France in 2012 were identified and followed until the end of 2015. Cardiac device infections (CDIs) were identified based on coding using the French classification for procedures [Classification Commune des Actes Médicaux (CCAM)] and International Classification of Diseases (ICD-10). Associated costs were estimated based on direct costs from the perspective of the French social security system. In total 78 267 CIED patients (72% de novo implants) were identified (15% defibrillators; 84% pacemakers). The 36-month infection rate associated with de novo defibrillator-only implants, as well as for cardiac resynchronisation therapy - defibrillators (CRT-Ds) was 1.6%. The CDI risk was 2.9% and 3.9% for replacement ICDs and CRT-Ds. Infection rates were lower for de novo single-chamber pacemaker (SCP)/dual-chamber pacemaker (DCP) (0.5%) and cardiac resynchronisation therapy - pacemaker (CRT-P) implants (1.0%), while for replacement procedures the risk increased to 1.4% (SCP/DCP) and 1.3% (CRT-P). Mean infection-related costs over 24 months were €20 623 and €23 234 for CDIs associated with replacement and de novo procedures, and overall costs were not significantly different between pacemaker and defibrillator patients. Conclusion: Cardiac device infections in France are associated with substantial costs, when considering inpatient hospitalizations. Strategies to minimize the rate of CIED infection should be a priority for health care providers and payers.

Cost-effectiveness of digoxin, pacing, and direct current cardioversion for conversion of atrial flutter in neonates.

IntroductionNewborn atrial flutter can be treated by medications, pacing, or direct current cardioversion. The purpose is to compare the cost-effectiveness of digoxin, pacing, and direct current cardioversion for the treatment of atrial flutter in neonates.Materials and methodsA decision tree model was developed comparing the efficacy and cost of digoxin, pacing, and direct current cardioversion based on a meta-analysis of published studies of success rates of cardioversion of neonatal atrial flutter (age<2 months). Patients who failed initial attempt at cardioversion progressed to the next methodology until successful. Data were analysed to assess the cost-effectiveness of these methods with cost estimates obtained from 2015 Medicare reimbursement rates. RESULTS: The cost analysis for cardioversion of atrial flutter found the most efficient method to be direct current cardioversion at a cost of $10 304, pacing was next at $11 086, and the least cost-effective was digoxin at $14 374. The majority of additional cost, regardless of method, was from additional neonatal ICU day either owing to digoxin loading or failure to covert. Direct current cardioversion remains the most cost-effective strategy by sensitivity analyses performed on pacing conversion rate and the cost of the neonatal ICU/day. Direct current cardioversion remains cost-effective until the assumed conversion rate is below 64.6%. CONCLUSION: The most cost-efficient method of cardioverting a neonate with atrial flutter is direct current cardioversion. It has the highest success rates based on the meta-analysis, shorter length of stay in the neonatal ICU owing to its success, and results in cost-savings ranging from $800 to $4000 when compared with alternative approaches.

EuroEco (European Health Economic Trial on Home Monitoring in ICD Patients): a provider perspective in five European countries on costs and net financial impact of follow-up with or without remote monitoring.

AIM: Remote follow-up (FU) of implantable cardiac defibrillators (ICDs) allows for fewer in-office visits in combination with earlier detection of relevant findings. Its implementation requires investment and reorganization of care. Providers (physicians or hospitals) are unsure about the financial impact. The primary end-point of this randomized prospective multicentre health economic trial was the total FU-related cost for providers, comparing Home Monitoring facilitated FU (HM ON) to regular in-office FU (HM OFF) during the first 2 years after ICD implantation. Also the net financial impact on providers (taking national reimbursement into account) and costs from a healthcare payer perspective were evaluated. METHODS AND RESULTS: A total of 312 patients with VVI- or DDD-ICD implants from 17 centres in six EU countries were randomised to HM ON or OFF, of which 303 were eligible for data analysis. For all contacts (in-office, calendar- or alert-triggered web-based review, discussions, calls) time-expenditure was tracked. Country-specific cost parameters were used to convert resource use into monetary values. Remote FU equipment itself was not included in the cost calculations. Given only two patients from Finland (one in each group) a monetary valuation analysis was not performed for Finland. Average age was 62.4 ± 13.1 years, 81% were male, 39% received a DDD system, and 51% had a prophylactic ICD. Resource use with HM ON was clearly different: less FU visits (3.79 ± 1.67 vs. 5.53 ± 2.32; P < 0.001) despite a small increase of unscheduled visits (0.95 ± 1.50 vs. 0.62 ± 1.25; P < 0.005), more non-office-based contacts (1.95 ± 3.29 vs. 1.01 ± 2.64; P < 0.001), more Internet sessions (11.02 ± 15.28 vs. 0.06 ± 0.31; P < 0.001) and more in-clinic discussions (1.84 ± 4.20 vs. 1.28 ± 2.92; P < 0.03), but with numerically fewer hospitalizations (0.67 ± 1.18 vs. 0.85 ± 1.43, P = 0.23) and shorter length-of-stay (6.31 ± 15.5 vs. 8.26 ± 18.6; P = 0.27), although not significant. For the whole study population, the total FU cost for providers was not different for HM ON vs. OFF [mean (95% CI): €204 (169-238) vs. €213 (182-243); range for difference (€-36 to 54), NS]. From a payer perspective, FU-related costs were similar while the total cost per patient (including other physician visits, examinations, and hospitalizations) was numerically (but not significantly) lower. There was no difference in the net financial impact on providers [profit of €408 (327-489) vs. €400 (345-455); range for difference (€-104 to 88), NS], but there was heterogeneity among countries, with less profit for providers in the absence of specific remote FU reimbursement (Belgium, Spain, and the Netherlands) and maintained or increased profit in cases where such reimbursement exists (Germany and UK). Quality of life (SF-36) was not different. CONCLUSION: For all the patients as a whole, FU-related costs for providers are not different for remote FU vs. purely in-office FU, despite reorganized care. However, disparity in the impact on provider budget among different countries illustrates the need for proper reimbursement to ensure effective remote FU implementation.

Project My Heart Your Heart: An Idea Whose Time Has Come.

It is estimated that nearly 1 million patients in low-income countries die every year from bradyarrhythmias coupled with no access to a pacemaker. At the same time, it is estimated that tens of thousands of used devices could be harvested from hospitals, funeral homes, and crematories in wealthy nations if such a practice was legal and proven to be safe and efficacious. Project My Heart Your Heart is a collaborative, multinational effort with a goal of making pacemaker recycling a reality. Since its inception 4 years ago, the project has studied beliefs and attitudes of this idea among patients, pacemaker recipients, funeral home directors, and arrhythmia specialists. The project has explored the safety and efficacy of this practice in several small pilot studies. Nearly 15,000 used devices have been received and evaluated. Efforts to fully define optimal methods for sterilization and device processing have progressed positively. Safe, effective pacemaker recycling is possible and is generally supported by the public, patients, and cardiovascular specialists. An ongoing dialogue with the FDA will hopefully lead to a large pivotal study in five countries which will definitively establish this practice including optimal strategies for device removal, interrogation, sterilization, handling, implantation, and follow-up at charitable pacemaker facilities servicing low income patients throughout the world.

Remote follow-up of pacemakers in a selected population of debilitated elderly patients.

AIMS: The majority of patients with pacemakers are very elderly, many being >85-years old. They often suffer from serious illnesses and have great difficulty in walking. The aim of our study was to compare remote pacemaker monitoring with in-home checks of pacemakers, in terms of applicability, efficacy, and cost in a selected population of debilitated elderly patients. METHODS AND RESULTS: We selected 72 subjects (mean age 87 ± 8 years) among elderly debilitated patients with Medtronic pacemakers, compatible with the Carelink(®) remote monitoring system (13 patients with DDD pacemaker; 59 patients with single-lead VDD pacemaker). Remote follow-up was compared with in-home checks performed by nurses in 326 patients in similar clinical conditions. A total of 190 transmissions were received by remote monitoring (mean transmissions per month: 7.0; mean per patient: 2.6; range 1-6) during 27 months of follow-up. In this period, seven pacemakers were replaced owing to battery exhaustion, after a mean of 6.7 years from implantation. The occurrence of atrial or ventricular high-rate episodes was reported in 98 transmissions (53%). Nineteen patients died (annual mortality: 11.7%). On comparing the costs borne by the hospital for in-home checks, both for medical personnel and transportation, the estimated average saving was €32 per year per patient. CONCLUSION: Our study shows that the remote follow-up of pacemakers is a reliable, effective, and cost-saving procedure in elderly, debilitated patients. Moreover, remote controls provided an accurate and early diagnosis of arrhythmia occurrence.

The use of imaging for electrophysiological and devices procedures: a report from the first European Heart Rhythm Association Policy Conference, jointly organized with the European Association of Cardiovascular Imaging (EACVI), the Council of Cardiovascular Imaging and the European Society of Cardiac Radiology.

Implantations of cardiac devices therapies and ablation procedures frequently depend on accurate and reliable imaging modalities for pre-procedural assessments, intra-procedural guidance, detection of complications, and the follow-up of patients. An understanding of echocardiography, cardiovascular magnetic resonance imaging, nuclear cardiology, X-ray computed tomography, positron emission tomography, and vascular ultrasound is indispensable for cardiologists, electrophysiologists as well as radiologists, and it is currently recommended that physicians should be trained in several imaging modalities. There are, however, no current guidelines or recommendations by electrophysiologists, cardiac imaging specialists, and radiologists, on the appropriate use of cardiovascular imaging for selected patient indications, which needs to be addressed. A Policy Conference on the use of imaging in electrophysiology and device management, with representatives from different expert areas of radiology and electrophysiology and commercial developers of imaging and device technologies, was therefore jointly organized by European Heart Rhythm Association (EHRA), the Council of Cardiovascular Imaging and the European Society of Cardiac Radiology (ESCR). The objectives were to assess the state of the level of evidence and a first step towards a consensus document for currently employed imaging techniques to guide future clinical use, to elucidate the issue of reimbursement structures and health economy, and finally to define the need for appropriate educational programmes to ensure clinical competence for electrophysiologists, imaging specialists, and radiologists.

Cost-of-illness study of patients subjected to cardiac rhythm management devices implantation: results from a single tertiary centre.

AIMS: The aim of the present study is to estimate the procedure (implantation) cost, the total hospitalization cost and annual follow-up cost, in patients subjected to pacemaker (PM) and implantable cardioverter-defibrillator (ICD) implantation. METHODS AND RESULTS: A single-center, prospective, cost-of-illness study was conducted between August 2008 and July 2009. In total, 464 consecutive patients were recruited (370 were subjected to PM implantation and 94 to ICD implantation). Resource data were assessed at patients' enrolment in the study and at 6th and 12th months of patients' follow-up. Then, the procedure cost, the total hospitalization cost as well as the annual patients' follow up costs were calculated using a bottom-up approach. The mean (95% confidence interval) procedure cost of PM and ICD implantation (including the costs of devices, electrodes, other supplies, and personnel's time) was calculated to be €1803 (€1758-€1858) and €13,521 (€13,153-€13,892), respectively. The mean total hospitalization cost (including procedure cost, hospitalization cost, cost of laboratory and imaging diagnostic examinations and the indirect cost attributed to productivity lost due to patient's hospitalization) was €3926 (€3711-€4167) for PM and €17,764 (€16,852-€18,692) for ICD. The mean annual cost (direct and indirect) was €1816 (€1433-€2421) for PM and €2819 (€2115-€3703) for ICD. No difference was detected in the annual cost between patients with initial implantation and replacement. CONCLUSION: These data revealed that although these devices are associated with a relatively high upfront cost, the annual societal cost following the implantation is low. Therefore, implantation of such devices should be encouraged since these devices reduce the morbidity and mortality without a high economic burden to society.

Health economics and the European Heart Rhythm Association.

The management of healthcare is becoming extremely complex in developed countries, as a result of increasing age of the population and increasing costs of care, coupled with diminishing resources due to global financial crisis. This situation threatens access to appropriate care, and a more or less explicit rationing of some types of treatment may occur in 'real world' clinical practice. This is particularly true for those treatments or interventions with a relatively high up-front cost, such as cardioverter defibrillators, devices for cardiac resynchronization therapy or ablation procedures for atrial fibrillation. The European Heart Rhythm Association (EHRA) is strongly convinced that the skills of electrophysiologists and cardiologists responsible for the management of rhythm disorders have to evolve, also embracing the knowledge of health economics, clinical epidemiology, health-care management and outcome research. These disciplines do not belong to what is considered as the conventional cultural background of physicians, but knowledge of comparative cost effectiveness and of other economic approaches nowadays appears fundamental for a dialogue with a series of stakeholders, such as policy makers, politicians, and administrators, involved in budgeting the activity of hospitals and health-care services, as well as in approaching health technology assessment.

Economic implications and cost-effectiveness of implantable cardioverter defibrillator and cardiac resynchronization therapy.

Use of implantable cardioverter defibrillators (ICDs) and/or cardiac resynchronization therapy reduces mortality among several high-risk cohorts, primarily those with left ventricular systolic dysfunction and heart failure. Since the advent of these technologies, concerns regarding the high initial costs of device implantation have been considered a potential barrier to widespread adoption. Despite such concerns, the use of these devices for primary or secondary prevention of sudden cardiac death seems to be cost-effective when compared with national standards. Moreover, ICDs have been shown to be cost-effective in several health care systems and specialized populations such as those with high-risk long QT syndrome and hypertrophic cardiomyopathy.

Tracing the European course of cardiac resynchronization therapy from 2006 to 2008.

Cardiac resynchronization therapy (CRT) is a highly efficient treatment modality for patients with severe congestive heart failure and intraventricular dyssynchrony. However, the high individual cost and technical complexity of the implantation may limit its widespread utilization. The European Heart Rhythm Association (EHRA) launched a project to assess treatment of arrhythmias in all European Society of Cardiology member countries in order to have a platform for a progressive harmonization of arrhythmia treatment. As a result, two EHRA White Books have been published in 2008 and 2009 based on governmental, insurance, and professional society data. Our aim was to analyse the local differences in the utilization of CRT, based on these surveys. A total of 41 countries provided enough data to analyse years 2006-2008. Significant differences were found in the overall number of implantations and the growth rate between 2006 and 2008. Other contributing factors include local reimbursement of CRT, the existence of national guidelines, and a high number of conventional implantable cardioverter-defibrillator implantations, while GDP or healthcare spending has less effect. Focusing on improving these factors may increase the availability of CRT in countries where it is currently underutilized.

[Update on current care guidelines. Current care guideline: cardiac pacemaker therapy]. / Sydämen tahdistinhoito.

The article presents the Finnish national guidelines for cardiac pacemaker therapy, comprising bradycardia pacing, cardiac resynchronisation therapy and implantable cardioverter-defibrillator therapy. These guidelines describe indications, the implantation technique, effectiveness, complications and patient follow-up. Emphasised are the novel aspects of bradycardia pacing therapy and the utility of cardiac resynchronisation therapy in the treatment of severe heart failure. The utility of prophylactic implantable cardioverter-defibrillators also receives emphasis. A particular focus lies in increasing awareness of advanced device therapy and the identification of patients who would benefit, in terms of improved quality of life and prolonged survival, from treatments which are clearly also cost-effective.

Implantation of the Micra transcatheter pacing system: Single Polish center experience with the real costs of hospitalization analysis.

BACKGROUND: The Micra transcatheter pacing system (TPS) is a miniaturized, single-chamber pacemaker system. Study reported herein is an initial experience with implantation of the Micra TPS. METHODS: The leadless pacemaker was implanted in 10 patients with standard indications for a permanent pacemaker implantation. All hospitalization costs were calculated for all patients. RESULTS: The mean age of the patients was 75 ± 7.1 years, 6 were men and 4 were women. Four patients had permanent atrial fibrillation as the basal rhythm and 6 patients had sinus rhythm. All patients had at least one relative contraindication that precluded the use of a traditional pacing system. Mean intraoperative ventricular sensing amplitude was 10.6 ± 5.4 mV, impedance 843 ± 185 ohms, and pacing threshold at 0.24 ms was 0.56 ± 0.23 V. At discharge, those values were 13.9 ± 5.6 mV, 667 ± 119 ohms and 0.47 ± 0.17, respectively. The mean duration of implantation procedure was 82 min, while mean fluoroscopy time was 3.5 min. Two patients developed hematoma at the groin puncture site post-implantation. In 1 case there was a need for erythrocyte mass transfusion and surgical intervention. Mean total time of hospitalization was 26 days and time from procedure to discharge 12 days. Average cost of hospitalization per 1 patient was 11,260.15 EUR minimal cost was 9,052.68 EUR, while maximal cost was 16,533.18 EUR. CONCLUSIONS: Implantation of leadless pacemakers is feasible, safe and provides advantages over the conventional system. Hospitalization costs vary for individual patients in wide range.

Cardiac resynchronization therapy in combination with implantable cardioverter-defibrillator.

Device therapy for heart failure has a spectacular development during the last 10 years. Patients with chronic heart failure might benefit from electrical therapy with a view to: (i) resynchronize the failing and dyssynchronized heart and improve its mechanical performance or (ii) prevent the risk of sudden death by automatic defibrillation. These two therapies can be applied together with a combined device, the biventricular implantable cardioverter-defibrillator (CRT-D). Today, the proportion of CRT-D devices among all CRT devices implanted around the world is more than 75% and more than 85% in the USA. This review article will try to answer some important questions for clinical practice: is the growing use of CRT-D devices supported by clinical evidence? Is the risk-benefit profile of CRT-D favourable in particular in mildly symptomatic patients?

Cost-utility analysis on telemonitoring of users with pacemakers: The PONIENTE study.

INTRODUCTION: Few studies have confirmed the cost-saving of telemonitoring of users with pacemakers (PMs). The purpose of this controlled, non-randomised, non-masked clinical trial was to perform an economic assessment of telemonitoring (TM) of users with PMs and check whether TM offers a cost-utility alternative to conventional follow-up in hospital. METHODS: Eighty-two patients implanted with an internet-based transmission PM were selected to receive either conventional follow-up in hospital ( n = 52) or TM ( n = 30) from their homes. The data were collected during 12 months while patients were being monitored. The economic assessment of the PONIENTE study was performed as per the perspectives of National Health Service (NHS) and patients. A cost-utility analysis was conducted to measure whether the TM of patients with PMs is cost-effective in terms of costs per gained quality-adjusted life years (QALYs). RESULTS: There was a significant cost-saving for participants in the TM group in comparison with the participants in the conventional follow-up group. From the NHS's perspective, the patients in the TM group gained 0.09 QALYs more than the patients in the conventional follow-up group over 12 months, with a cost saving of 57.64% (€46.51 versus €109.79, respectively; p < 0.001) per participant per year. In-office visits were reduced by 52.49% in the TM group. The costs related to the patient perspective were lower in the TM group than in the conventional follow-up group (€31.82 versus €73.48, respectively; p < 0.005). The costs per QALY were 61.68% higher in the in-office monitoring group. DISCUSSION: The cost-utility analysis performed in the PONIENTE study showed that the TM of users with PMs appears to be a significant cost-effective alternative to conventional follow-up in hospital.

Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial.

INTRODUCTION: Permanent artificial pacemaker implantation is a safe and effective treatment for bradycardia and is associated with extended longevity and improved quality of life. However, the most common long-term complication of standard pacemaker therapy is pacemaker-associated heart failure. Pacemaker follow-up is potentially an opportunity to screen for heart failure to assess and optimise patient devices and medical therapy. METHODS AND ANALYSIS: The study is a multicentre, phase-3 randomised trial. The 1200 participants will be people who have a permanent pacemaker for bradycardia for at least 12 months, randomly assigned to undergo a transthoracic echocardiogram with their pacemaker check, thereby tailoring their management directed by left ventricular function or the pacemaker check alone, continuing with routine follow-up. The primary outcome measure is time to all-cause mortality or heart failure hospitalisation. Secondary outcomes include external validation of our risk stratification model to predict onset of heart failure and quality of life assessment. ETHICS AND DISSEMINATION: The trial design and protocol have received national ethical approval (12/YH/0487). The results of this randomised trial will be published in international peer-reviewed journals, communicated to healthcare professionals and patient involvement groups and highlighted using social media campaigns. TRIAL REGISTRATION NUMBER: NCT01819662.

Clinical and organizational management of cardiac implantable electronic device replacements: an Italian Survey promoted by AIAC (Italian Association of Arrhythmology and Cardiac Pacing).

AIMS: The aim of this survey was to assess the management and organization of cardiac implantable electronic device (CIED) replacement in Italy. METHODS: A questionnaire consisting of 24 questions on organizational aspects and on the peri-procedural management of anticoagulant therapies and antibiotic prophylaxis was sent via the Internet to 154 Italian arrhythmia centers. RESULTS: A total of 103 out of 154 centers completed the questionnaire (67% response rate). In 43% of the centers, the procedures were performed under day-case admission, in 40% under ordinary admission, and in 17% under either day-case or ordinary admission. The most frequent reason (66%) for choosing ordinary admission rather than day-case admission was to obtain full reimbursement. Although warfarin therapy was continued in 73% of the centers, nonvitamin K oral anticoagulants were discontinued, without bridging, 24 h or less prior to replacement procedures in 88%. Prophylactic antibiotic therapy was systematically administered in all centers; in 97%, the first antibiotic dose was administered 1-2 h prior to procedures. Local antibacterial envelopes were also used in 43% of the centers in patients with a higher risk of device infection. CONCLUSION: This survey provides a representative picture of how CIED replacements are organized and managed in current Italian clinical practice. The choice of the type of hospitalization (short versus ordinary) was more often motivated by economic reasons (reimbursement of the procedure) than by clinical and organizational factors. Peri-procedural management of anticoagulation and prophylactic antibiotic therapy was consistent with current scientific evidence.

Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Replacement.

OBJECTIVES: This study investigated whether left ventricular (LV) stimulation via a guidewire-reduced procedure duration while maintaining efficacy and safety compared with standard right ventricular (RV) stimulation. BACKGROUND: Rapid ventricular pacing is necessary to ensure cardiac standstill during transcatheter aortic valve replacement (TAVR). METHODS: This is a prospective, multicenter, single-blinded, superiority, randomized controlled trial. Patients undergoing transfemoral TAVR with a SAPIEN valve (Edwards Lifesciences, Irvine, California) were allocated to LV or RV stimulation. The primary endpoint was procedure duration. Secondary endpoints included efficacy, safety, and cost at 30 days. RESULTS: Between May 2017 and May 2018, 307 patients were randomized, but 4 were excluded because they did not receive the intended treatment: 303 patients were analyzed in the LV (n = 151) or RV (n = 152) stimulation groups. Mean procedure duration was significantly shorter in the LV stimulation group (48.4 ± 16.9 min vs. 55.6 ± 26.9 min; p = 0.0013), with a difference of -0.12 (95% confidence interval: -0.20 to -0.05) in the log-transformed procedure duration (p = 0.0012). Effective stimulation was similar in the LV and RV stimulation groups: 124 (84.9%) versus 128 (87.1%) (p = 0.60). Safety of stimulation was also similar in the LV and RV stimulation groups: procedural success occurred in 151 (100%) versus 151 (99.3%) patients (p = 0.99); 30-day MACE-TAVR (major adverse cardiovascular event-transcatheter aortic valve replacement) occurred in 21 (13.9%) versus 26 (17.1%) patients (p = 0.44); fluoroscopy time (min) was lower in the LV stimulation group (13.48 ± 5.98 vs. 14.60 ± 5.59; p = 0.02), as was cost (€18,807 ± 1,318 vs. €19,437 ± 2,318; p = 0.001). CONCLUSIONS: Compared with RV stimulation, LV stimulation during TAVR was associated with significantly reduced procedure duration, fluoroscopy time, and cost, with similar efficacy and safety. (Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVR [EASY TAVI]; NCT02781896).