Spanish implantable cardioverter-defibrillator registry. 19th official report of Heart Rhythm Association of the Spanish Society of Cardiology (2022).

INTRODUCTION AND OBJECTIVES: This article presents data on implantable cardioverter-defibrillator implants in Spain in 2022. METHODS: The data were collected from implantation centers, which voluntarily completed a data collection sheet during the implantation process, either manually or through a web page. RESULTS: In 2022, 170 hospitals participated in the registry. A total of 7693 forms were received compared with the 7970 reported by Eucomed (European Confederation of Medical Suppliers Associations), representing 96.5% of the devices. The total rate of registered implants was 162/million inhabitants (168 according to Eucomed), showing a slight increase compared with previous years. Disparities persisted among autonomous communities and Spain continued to have the lowest implantation rate among countries participating in Eucomed. CONCLUSIONS: The data from the registry for 2022 reflect the complete recovery of activity after the impact of the COVID-19 pandemic in 2020. Despite a slight improvement, there was no significant change in our position in Europe or in the substantial differences among autonomous communities.

Multicenter prospective comparison of conventional and high-power short duration radiofrequency application for pulmonary vein isolation: the high-power short-duration radiofrequency application for faster and safer pulmonary vein ablation (POWER FAST III) trial.

BACKGROUND: Electrical isolation of pulmonary veins (PV) with high-power short-duration (HPSD) radiofrequency application (RFa) may reduce the duration of atrial fibrillation (AF) ablation, without compromising the procedural efficacy and safety in comparison with the conventional approach. This hypothesis has been generated in several observational studies; the POWER FAST III will test it in a randomized multicenter clinical trial. METHODS: It is a multicenter randomized, open-label and non-inferiority clinical trial with two parallel groups. AF ablation using 70 W and 9-10 s RFa is compared with the conventional technique using 25-40 W RFa guided by numerical lesion indexes. The main efficacy objective is the incidence of atrial arrhythmia recurrences electrocardiographically documented during 1-year follow-up. The main safety objective is the incidence of endoscopically detected esophageal thermal lesions (EDEL). This trial includes a substudy of incidence of asymptomatic cerebral lesions detected by magnetic resonance imaging (MRI) after ablation. RESULTS: A randomized clinical trial compares for the first time high-power short-duration and conventional ablation in order to obtain data about the efficacy and safety of the high-power technique in an adequate methodological context. CONCLUSIONS: The results of the POWER FAST III could support the use of the high-power short-duration ablation in clinical practice. REGISTRATION: ClinicalTrials.gov: NTC04153747.

Spanish implantable cardioverter-defibrillator registry. 18th official report of the Heart Rhythm Association of the Spanish Society of Cardiology (2021).

INTRODUCTION AND OBJECTIVES: This article presents the data corresponding to implantable cardioverter-defibrillator (ICD) implantations in Spain in 2021. METHODS: The data were drawn from implanting centers, which voluntarily completed a data collection sheet during the procedure. RESULTS: In 2021, 7496 implant data sheets were received, compared with 7743 reported by Eucomed (European Confederation of Medical Suppliers Associations), indicating that data were collected from 96.8% of the devices implanted in Spain. Data completion ranged from 99.9% for "name of implanting hospital" to 8.9% for "implanting hospital". In 2021, 199 hospitals participated in the registry, exceeding the figures of previous years, with around 170 participating hospitals. The total rate of registered implants was 158/million inhabitants (163 according to Eucomed), making 2021 the year with the highest activity. However, the registry continues to show significant differences among the various autonomous communities and the lowest implantation rate of all the European countries participating in Eucomed. CONCLUSIONS: The Spanish implantable cardioverter-defibrillator registry for 2021 recorded an increase in the number of ICD implantations, reflecting the recovery of hospital activity after the initial impact of the COVID-19 pandemic in 2020. Although the total number of implants has increased in Spain, figures are still much lower than the European Union average, with differences persisting among Spanish autonomous communities.

Acute Hemodynamic Effects of Simultaneous and Sequential Multi-Point Pacing in Heart Failure Patients With an Expected Higher Rate of Sub-response to Cardiac Resynchronization Therapy: Results of Multicenter SYNSEQ Study.

The aim of the SYNSEQ (Left Ventricular Synchronous vs. Sequential MultiSpot Pacing for CRT) study was to evaluate the acute hemodynamic response (AHR) of simultaneous (3P-MPP syn) or sequential (3P-MPP seq) multi-3-point-left-ventricular (LV) pacing vs. single point pacing (SPP) in a group of patients at risk of a suboptimal response to cardiac resynchronization therapy (CRT). Twenty five patients with myocardial scar or QRS ≤ 150 or the absence of LBBB (age: 66 ± 12 years, QRS: 159 ± 12 ms, NYHA class II/III, LVEF ≤ 35%) underwent acute hemodynamic assessment by LV + dP/dtmax with a variety of LV pacing configurations at an optimized AV delay. The change in LV + dP/dt max (%ΔLV + dP/dt max) with 3P-MPP syn (15.6%, 95% CI: 8.8%-22.5%) was neither statistically significantly different to 3P-MPP seq (11.8%, 95% CI: 7.6-16.0%) nor to SPP basal (11.5%, 95% CI:7.1-15.9%) or SPP mid (12.2%, 95% CI:7.9-16.5%), but higher than SPP apical (10.6%, 95% CI:5.3-15.9%, p = 0.03). AHR (defined as a %ΔLV + dP/dt max ≥ 10%) varied between pacing configurations: 36% (9/25) for SPP apical, 44% (11/25) for SPP basal, 54% (13/24) for SPP mid, 56% (14/25) for 3P-MPP syn and 48% (11/23) for 3P-MPP seq.Fifteen patients (15/25, 60%) had an AHR in at least one pacing configuration. AHR was observed in 10/13 (77%) patients with a LBBB but only in 5/12 (42%) patients with a non-LBBB (p = 0.11). To conclude, simultaneous or sequential multipoint pacing compared to single point pacing did not improve the acute hemodynamic effect in a suboptimal CRT response population. Clinical Trial Registration: ClinicalTrials.gov, identifier: NCT02914457.

Outcomes of leadless pacemaker implantation in patients with mechanical heart valves.

INTRODUCTION: Device infections constitute a major complication of transvenous pacemakers. Mechanical heart valves (MHV) increase the risk of infective endocarditis (IE) and pacemaker infection, requiring lifelong vitamin K-antagonists (VKA), which may affect patient management. Leadless pacemakers (LP) are associated with low infection rates, posing an attractive option in MHV patients requiring permanent pacing. This study describes outcomes following LP implantation in patients with MHV. METHODS: This is a multicenter, observational, retrospective study including consecutive patients implanted with an LP at 5 centers between June 2015 and January 2020. Procedural outcomes, antithrombotic management, complications, performance during follow-up and episodes of bacteremia and IE were compared between patients with and without an MHV (MHV and non-MHV groups). RESULTS: Four hundred fifty-nine patients were included (74 in the MHV group, 16.1%, and 385 in the non-MHV group, 83.9%). Procedural outcomes and acute electrical performance were comparable between groups. Vascular complications and cardiac perforation occurred in 2.7 versus 2.3% (p = 1) and 0% versus 0.8% (p = 1) in the MHV group and non-MHV group. One case of IE occurred in the MHV group and 2 in the non-MHV group. In MHV patients, uninterrupted VKA was used in 83.8%, whereas 16.2% were heparin-bridged. Vascular complication or tamponade occurred in 1 (8.3%) MHV heparin-bridged patient versus 1 (1.6%) MHV uninterrupted VKA patient (p = .3). CONCLUSION: LP implantation outcomes in MHV patients are comparable to the general LP population. Device-related infections are rare following LP implantation, including in patients with MHV. In the MHV group, periprocedural anticoagulation management was not associated with significantly different rates of tamponade or vascular complication.

Personalized assessment of the cumulative complication risk of the atrial fibrillation ablation track: The AF-TRACK calculator.

Background: Atrial fibrillation (AF) ablation strategy is associated with a non-negligible risk of complications and often requires repeat procedures (AF ablation track), implying repetitive exposure to procedural risk. Objective: The purpose of this study was to develop and validate a model to estimate individualized cumulative risk of complications in patients undergoing the AF ablation track (Atrial Fibrillation TRAck Complication risK [AF-TRACK] calculator). Methods: The model was derived from a multicenter cohort including 3762 AF ablation procedures in 2943 patients. A first regression model was fitted to predict the propensity for repeat ablation. The AF-TRACK calculator computed the risk of AF ablation track complications, considering the propensity for repeat ablation. Internal (cross-validation) and external (independent cohort) validation were assessed for discrimination capacity (area under the curve [AUC]) and goodness of fit (Hosmer-Lemeshow [HL] test). Results: Complications (N = 111) occurred in 3.7% of patients (2.9% of procedures). Predictors included female sex, heart failure, sleep apnea syndrome, and repeat procedures. The model showed fair discrimination capacity to predict complications (AUC 0.61 [0.55-0.67]) and likelihood of repeat procedure (AUC 0.62 [0.60-0.64]), with good calibration (HL χ2 12.5; P = .13). The model maintained adequate discrimination capacity (AUC 0.67 [0.57-0.77]) and calibration (HL χ2 5.6; P = .23) in the external validation cohort. The validated model was used to create the Web-based AF-TRACK calculator. Conclusion: The proposed risk model provides individualized estimates of the cumulative risk of complications of undergoing the AF ablation track. The AF-TRACK calculator is a validated, easy-to-use, Web-based clinical tool to calibrate the risk-to-benefit ratio of this treatment strategy.

Spanish Implantable Cardioverter-defibrillator Registry. 17th Official Report of the Heart Rhythm Association of the Spanish Society of Cardiology (2020).

INTRODUCTION AND OBJECTIVES: We present the data corresponding to implantable cardioverter-defibrillator (ICD) implants in Spain in 2020. METHODS: The data in this registry were drawn from implantation centers, which voluntarily completed a data collection sheet. RESULTS: In 2020, 7056 implant sheets were received compared with 7106 reported by Eucomed (European Confederation of Medical Suppliers Associations), indicating that data were collected from 99% of the devices implanted in Spain. Completion of the implant sheet ranged from 99.8% for the field "name of the implanting hospital" to 2.6% for the variable "referral hospital". A total of 173 hospitals performed ICD implants and participated in the registry, which is a similar figure to that in 2019 (n=172). The total rate of registered implants was 149/million inhabitants (150 according to Eucomed), revealing a slight reduction in implants in Spain in 2020 as a result of the impact of the COVID-19 pandemic. This reduction was uneven among the autonomous communities. CONCLUSIONS: The Spanish Implantable Cardioverter Defibrillator Registry for 2020 shows an improvement in the rate of implants reported and a reduction in the number of ICD implants, which likely reflects the decrease in hospital activity not related to the treatment of COVID-19 infection. Similar to previous years, the total number of implants in Spain is still much lower than the average for the European Union, with an increase in the differences between Spanish autonomous communities.

The RITHMI study: diagnostic ability of a heart rhythm monitor for automatic detection of atrial fibrillation.

INTRODUCTION AND OBJECTIVES: Early detection of atrial fibrillation (AF) is a priority to reduce embolic events by initiating oral anticoagulation therapy. The aim of this study was to evaluate the diagnostic ability of a wrist device designed for automatic AF detection. METHODS: RITHMI is a prospective, comparative, observational study that included 167 patients referred to a cardiology outpatient clinic for a general consultation or for electrical cardioversion. The study evaluated the ability of a wrist monitor that uses a photoplethysmography (PPG) signal and an electrocardiographic lead to automatically detect AF compared with diagnosis established by 2 cardiologists using the 12-lead electrocardiogram. RESULTS: The AF detection algorithm based on the PPG signal had a sensitivity of 91% and a specificity of 96% (diagnostic accuracy: 93%). The automatic algorithm based on the electrocardiographic signal had a sensitivity of 94% and a specificity of 96% (diagnostic accuracy: 95%). The 2 algorithms concurred in the diagnosis in 96% of the cases. Overall, the monitor had a sensitivity and specificity of 95% (diagnostic accuracy: 95% and Kappa index: 0.98). CONCLUSIONS: This study shows that automatic AF detection through the use of a heart rhythm monitor incorporating sensors and algorithms that analyze the PPG signal and the electrocardiographic signal corresponding to lead I is feasible and has high diagnostic accuracy.

Spanish Implantable Cardioverter-defibrillator Registry. 16th Official Report of the Heart Rhythm Association of the Spanish Society of Cardiology (2019).

INTRODUCTION AND OBJECTIVES: We present the data corresponding to implantable cardioverter-defibrillator (ICD) implants in Spain in 2019. METHODS: The data were drawn from implant centers voluntarily completing a data collection sheet. RESULTS: In 2019, 7003 implant sheets were received compared with the 7389 reported by Eucomed (European Confederation of Medical Suppliers Associations), indicating that data were collected from 94.8% of the devices implanted in Spain. Completion of the implant sheet ranged from 99.7% in the field "name of the implanting hospital" to 17.8% in the variable "reference hospital". In 2019, 172 hospitals performed ICD implants and participated in the registry, a figure similar to that of 2018 (173). The total rate of registered implants was 149/million inhabitants; the rate reported by Eucomed was 157. Although this value represents the highest in the historical series, it is still much lower than the average rate of ICD implants in Europe (303). CONCLUSIONS: The Spanish Implantable Cardioverter-Defibrillator Registry for 2019 reflects a growth in the number of ICD implants and is the year with the highest number of ICD implants in Spain. However, similar to previous years, the total number of implants in Spain is still much lower than the European Union average, with substantial differences between Spanish autonomous communities.

Spanish Implantable Cardioverter-defibrillator Registry. 15th Official Report of the Spanish Society of Cardiology Electrophysiology and Arrhythmias Section (2018).

INTRODUCTION AND OBJECTIVES: This article presents the data corresponding to automated implantable cardioverter-defibrillator (ICD) implants in Spain reported to the Spanish Registry in 2018. METHODS: The data in this registry include both primary implants and generator replacements and were gathered from a data collection sheet voluntarily completed by implantation centers. RESULTS: In 2018, 6421 implant sheets were received compared with 7077 reported by Eucomed (European Confederation of Medical Suppliers Associations). This represents data on 90.7% of the devices implanted in Spain. Compliance ranged between 99.6% for the field "name of the implanting hospital" and 12.4% for "population of residence". A total of 173 hospitals reported their data to the registry, representing a slight decrease compared with hospitals participating in 2017 (n=181). CONCLUSIONS: After the reduction in ICD implants in 2017, the number of implants increased in 2018, with the highest number of ICDs implanted in Spain. The total number of implants remains much lower than the European Union average, with substantial differences between autonomous communities.

Safety and efficiency of a common and simplified protocol for pacemaker and defibrillator surveillance based on remote monitoring only: a long-term randomized trial (RM-ALONE).

AIMS: This trial aimed to evaluate the safety and efficiency of a common and simplified protocol for the surveillance of cardiac implantable electronic devices based on remote monitoring (RM) in patients with pacemakers (PMs) and implantable cardiac defibrillators (ICDs) for at least 24 months. METHODS AND RESULTS: The RM-ALONE is a multicentre prospective trial that randomly assigned 445 patients in two groups, both followed by RM: the home monitoring-only (HMo) based on RM + remote interrogations (RIs) every 6 months and the HM + IO that adds in-office evaluations every 6 months to RM. Four hundred and forty-five patients were enrolled in the study, 294 PMs and 151 ICDs recipients. In the HMo group, 20% of patients experienced ≥1 major adverse cardiac event (MACE) vs. 19.5% in HM + IO group (P = 0.006 for non-inferiority). The proportion of patients with a PM/ICD who experienced ≥1 MACE was 15.2/29.3% in HMo group and 16.1/26.3% in HM + IO group (hazard ratio 0.95/1.15, 95% confidence interval 0.53-1.70/0.62-2.10). There were 789 in-office evaluations (136 in the HMo and 653 in the HM + IO; P < 0.001). There was a 79.2% reduction of in-office evaluations with no significant differences in unscheduled visits between groups: 122 (54.5%) in HMo and 101 (45.3%) in HM + IO; P = 0.15. The time a physician/nurse spent per patient/follow-up was significantly reduced in the HMo group: 4/5 min (0-30)/(1-30) vs. 10/10 min (0-40)/(1-40) in HM + IO (P < 0.0001). CONCLUSION: The RM-ALONE protocol common for ICD and PM surveillance, consisting of RM + RI every 6 months has proven safe and efficient in reducing hospital visits and staff workload.

Spanish Implantable Cardioverter-defibrillator Registry. 14th Official Report of the Spanish Society of Cardiology Electrophysiology and Arrhythmias Section (2017).

INTRODUCTION AND OBJECTIVES: The Spanish Automatic Defibrillator Registry has provided activity data since 2002. METHODS: The data in this registry are submitted by implantation centers that voluntarily complete a data collection sheet. RESULTS: During 2017, a total of 6273 implant sheets were received, compared with 6429 reported by Eucomed (European Confederation of Medical Suppliers Associations). Therefore, the registry contains data on 97.6% of the devices implanted in Spain. Compliance ranged from 99.7% for the field "name of the implanting hospital" to 46.1% for the variable "New York Heart Association functional class". A total of 181 hospitals reported data to the registry, representing an increase compared with the number of participating hospitals in 2016 (177) and in previous years (169 in 2015, 162 in 2014, 154 in 2013, and 153 in 2012). CONCLUSIONS: The number of implants per million inhabitants in Spain increased for several years but decreased in 2017. As in previous years, the total number of implants in Spain is still much lower than the European Union average, and the gap continues to widen. There are still substantial differences between autonomous communities.

Laser Balloon or Wide-Area Circumferential Irrigated Radiofrequency Ablation for Persistent Atrial Fibrillation: A Multicenter Prospective Randomized Study.

BACKGROUND: Pulmonary vein isolation is the cornerstone of ablation for persistent atrial fibrillation (AF). The role of balloon catheters in this patient population remains ill defined. We sought to compare efficacy and safety of the laser balloon (LB) with wide-area circumferential pulmonary vein isolation using irrigated radiofrequency current (RF) ablation and 3-dimensional mapping. METHODS AND RESULTS: In 6 European centers, patients with persistent AF were prospectively randomized. Follow-up included 3-day Holter ECG recordings and office visits at 3, 6, and 12 months. The primary efficacy end point was freedom from AF between 90 and 365 days after a single ablation. The primary safety end point was the incidence of any periprocedural complications. Of 152 enrolled patients, 134 (n=68 LB and 66 RF; 63% men; mean age, 66+10 years) with persistent AF (median AF history, 14 months; Q1-Q3, 7-36 months) underwent pulmonary vein isolation and completed the entire follow-up. Baseline parameters were similar in both groups. Procedure and fluoroscopy times were similar in both groups (135±38 and 14±9 minutes (LB) versus 128±51 and 11±9 minutes). The primary efficacy end point was met by 71.2% versus 69.3%, in the LB and RF groups, respectively (P=0.40). In the LB group, stroke (n=1), a false aneurysm (n=1), and phrenic nerve palsy (n=1) were observed. In the RF group, 2 patients developed a false aneurysm, and 1 patient needed surgical repair. CONCLUSIONS: An LB-guided strategy was associated with similar efficacy as wide-area circumferential pulmonary vein isolation using irrigated RF in patients with persistent AF. CLINICAL TRIAL REGISTRATION: https://www.clinicaltrials.org. Unique identifier: NCT01863472.

Cardiac Resynchronization Therapy With a Quadripolar Electrode Lead Decreases Complications at 6 Months: Results of the MORE-CRT Randomized Trial.

OBJECTIVES: The aim of this study was to test the hypothesis that a quadripolar left ventricular (LV) lead results in fewer LV lead-related events than a bipolar cardiac resynchronization therapy (CRT) system in a prospective randomized trial. BACKGROUND: Bipolar LV leads cannot be implanted at the optimal site in up to 10% of patients who need CRT, because of anatomic or technical challenges (pacing threshold, phrenic stimulation, or mechanical instability). METHODS: The MORE-CRT (More Options Available With a Quadripolar LV Lead Provide In-Clinic Solutions to CRT Challenges) trial enrolled 1,078 patients. Patients with indications for CRT defibrillator therapy were randomized into 2 groups in a 1:2 ratio: a group with a bipolar CRT lead system (the BiP group; any manufacturer) and a group with a quadripolar CRT system (the Quad group; Quartet LV lead). The primary endpoint was freedom from a composite endpoint of intraoperative and post-operative LV lead-related events at 6 months. RESULTS: A total of 1,074 of 1,078 patients (99%) were randomized and contributed to the primary endpoint. Freedom from the composite endpoint was significantly greater in the Quad than the BiP group (83.0% vs. 74.4%, p = 0.0002). The intraoperative component of the endpoint was met less frequently by Quad group patients (6.26% Quad vs. 12.1% BiP), whereas there was no difference for the post-operative component (7.1% Quad vs. 7.6% BiP). CONCLUSIONS: The Quartet LV system significantly reduced total LV lead-related events at 6 months after implantation compared with a bipolar CRT system. The reduction in events demonstrates the superiority of this quadripolar technology to effectively manage CRT patients. (More Options Available With a Quadripolar LV Lead Provide In-Clinic Solutions to CRT Challenges [MORE-CRT]; NCT01510652).

Improvement in hemodynamic response using a quadripolar LV lead.

BACKGROUND: The Quartet quadripolar lead (St. Jude Medical Inc., St. Paul, MN, USA) offers 10 different left ventricle pacing configurations that may further influence hemodynamic parameters compared to traditional bipolar pacing configurations. The purpose of this study was to evaluate whether pacing from additional quadripolar lead vectors could enhance cardiac output (CO). METHODS: For each patient, CO was measured in "no-pacing" and in all the 10 configurations available, within 7 days of implantation of the device. Tip-ring, tip-right ventricular coil (RVC), and ring-RVC vectors were considered as traditional vectors. The seven additional configurations available in the quadripolar lead were considered as nontraditional vectors. CO was measured by ECHO. The best configuration was defined as the one presenting the highest CO measurement within configurations, which have a capture threshold <3 V and a safety margin between the capture and the phrenic nerve stimulation thresholds. RESULTS: Fifty-one standard cardiac resynchronization therapy patients were enrolled. The mean of each patient's best CO obtained with traditional vectors was higher than the baseline nonpaced CO (4.16 L/min vs 3.64 L/min). The mean of each patient's best CO, including all 10 available configurations, was also higher than the baseline nonpaced CO (4.33 L/min vs 3.64 L/min). In addition, the mean of each patient's best CO obtained with the best configuration available through a quadripolar lead was better than the mean of each patient's best CO obtained with a traditional configuration. In 53% of patients, the best CO was obtained with a nontraditional vector unique to the quadripolar lead. CONCLUSIONS: A quadripolar lead offers multiple additional pacing options to increase CO acutely compared to conventional bipolar leads.

Usefulness of echo-guided cardiac resynchronization pacing in patients undergoing "ablate and pace" therapy for permanent atrial fibrillation and effects of heart rate regularization and left ventricular resynchronization.

An acute comparative study of right ventricular (RV) pacing and echocardiographically guided cardiac resynchronization pacing (CRP) was performed in patients who underwent "ablate and pace" therapy for permanent atrial fibrillation. It was hypothesized that optimized CRP guided by tissue Doppler echocardiography would exert an additive beneficial hemodynamic effect to that of rate regularization achieved through atrioventricular junction ablation. An acute intrapatient comparison of echocardiographic parameters was performed between baseline preablation values and RV pacing and CRP (performed <24 hours after ablation) in 50 patients. Optimized CRP configuration was defined as the modality of pacing corresponding to that of the shortest intra-left ventricular (LV) delay among simultaneous biventricular pacing, sequential biventricular pacing, and single-chamber pacing. The intra-LV delay was defined as the difference between the longest and the shortest activation time in the six basal segments of the left ventricle. Compared with preablation measures, the ejection fraction increased by 10.8% during RV pacing (19% in patients with intra-LV delays <47.5 ms and 3% in those with intra-LV delays >47.5 ms). Compared with RV pacing, CRP caused a 9.2% increase in the ejection fraction, a 6.8% decrease in LV systolic diameter, and a 17.3% decrease in mitral regurgitation area; LV dyssynchrony was reduced from 52 +/- 27 to 21 +/- 12 ms. Similar results were observed in patients with and without depressed systolic function and in patients with and without left bundle branch block. In conclusion, rate regularization achieved through atrioventricular junction ablation and RV pacing provides a favorable hemodynamic effect that is inversely related to the level of LV dyssynchrony. Minimizing LV dyssynchrony by means of optimized CRP yields an additional important benefit.