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.
Graphical Abstract
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.
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.
BACKGROUNDPulmonary 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 RESULTSIn 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.
CONCLUSIONSAn 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 REGISTRATIONhttps://www.clinicaltrials.org. Unique identifierNCT01863472.
Se presentan los datos de implantes de desfibrilador automático implantable en España en el año 2022.
Los datos provienen de los centros implantadores, que cumplimentaron voluntariamente una hoja de ...recogida de datos durante el implante, a mano o a través de una página web.
Durante 2022, han participado en el registro 170 hospitales. Se han recibido 7.693 formularios, frente a los 7.970 comunicados por la European Confederation of Medical Suppliers Associations (Eucomed), lo que representa un 96,5% de los dispositivos. La tasa total de implantes registrados fue 162/millón de habitantes (168 según Eucomed), un ligero incremento respecto a años anteriores. Las diferencias entre las comunidades autónomas persisten, así como nuestra última posición respecto a los países europeos que participan en la Eucomed.
Los datos del registro de 2022 reflejan la recuperación completa de la actividad tras el impacto de la pandemia de la COVID-19 en 2020. Pese a la leve mejora, se mantiene nuestra posición en Europa y también las grandes diferencias entre nuestras comunidades autónomas.
This article presents data on implantable cardioverter-defibrillator implants in Spain in 2022.
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.
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.
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.
Full English text available from:www.revespcardiol.org/en
This article presents data on implantable cardioverter-defibrillator implants in Spain in 2022.
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.
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.
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.
Se presentan los datos de implantes de desfibrilador automático implantable en España en el año 2022.
Los datos provienen de los centros implantadores, que cumplimentaron voluntariamente una hoja de recogida de datos durante el implante, a mano o a través de una página web.
Durante 2022, han participado en el registro 170 hospitales. Se han recibido 7.693 formularios, frente a los 7.970 comunicados por la European Confederation of Medical Suppliers Associations (Eucomed), lo que representa un 96,5% de los dispositivos. La tasa total de implantes registrados fue 162/millón de habitantes (168 según Eucomed), un ligero incremento respecto a años anteriores. Las diferencias entre las comunidades autónomas persisten, así como nuestra última posición respecto a los países europeos que participan en la Eucomed.
Los datos del registro de 2022 reflejan la recuperación completa de la actividad tras el impacto de la pandemia de la COVID-19 en 2020. Pese a la leve mejora, se mantiene nuestra posición en Europa y también las grandes diferencias entre nuestras comunidades autónomas.
Se presentan los datos correspondientes a los implantes de desfibrilador automático implantable (DAI) en España en el año 2021.
Los datos provienen de los centros implantadores, que cumplimentaron ...voluntariamente una hoja de recogida de datos durante el implante.
En 2021 se recibieron 7.496 formularios de implante, frente a los 7.743 comunicadas por Eucomed (European Confederation of Medical Suppliers Associations), lo que implica que se han recogido datos del 96,8% de los dispositivos implantados en España. El cumplimiento osciló entre el 99,9% en el campo «nombre del hospital implantador» y el 8,9% en la variable «hospital de referencia». En 2021, 199 hospitales han participado en el registro, lo cual supera las cifras de los años previos en que el número de participantes osciló alrededor de 170 hospitales. La tasa total de implantes registrados fue 158/millón de habitantes (163 según Eucomed), lo que la sitúa como el año con mayor actividad. Sin embargo, el registro sigue mostrando diferencias importantes entre las comunidades autónomas y la tasa de implante más baja de todos los países europeos participantes en Eucomed.
El Registro español de desfibrilador automático implantable del año 2021 recoge un incremento en el número de implantes de DAI y refleja la recuperación de la actividad hospitalaria tras el impacto inicial de la pandemia por COVID-19 durante 2020. A pesar del incremento en el número total de implantes en España, este sigue siendo muy inferior a la media de la Unión Europea y persisten las diferencias entre las comunidades autónomas españolas.
This article presents the data corresponding to implantable cardioverter-defibrillator (ICD) implantations in Spain in 2021.
The data were drawn from implanting centers, which voluntarily completed a data collection sheet during the procedure.
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.
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.
This article presents the data corresponding to implantable cardioverter-defibrillator (ICD) implantations in Spain in 2021.
The data were drawn from implanting centers, which voluntarily completed a ...data collection sheet during the procedure.
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.
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.
Se presentan los datos correspondientes a los implantes de desfibrilador automático implantable (DAI) en España en el año 2021.
Los datos provienen de los centros implantadores, que cumplimentaron voluntariamente una hoja de recogida de datos durante el implante.
En 2021 se recibieron 7.496 formularios de implante, frente a los 7.743 comunicadas por Eucomed (European Confederation of Medical Suppliers Associations), lo que implica que se han recogido datos del 96,8% de los dispositivos implantados en España. El cumplimiento osciló entre el 99,9% en el campo «nombre del hospital implantador» y el 8,9% en la variable «hospital de referencia». En 2021, 199 hospitales han participado en el registro, lo cual supera las cifras de los años previos en que el número de participantes osciló alrededor de 170 hospitales. La tasa total de implantes registrados fue 158/millón de habitantes (163 según Eucomed), lo que la sitúa como el año con mayor actividad. Sin embargo, el registro sigue mostrando diferencias importantes entre las comunidades autónomas y la tasa de implante más baja de todos los países europeos participantes en Eucomed.
El Registro español de desfibrilador automático implantable del año 2021 recoge un incremento en el número de implantes de DAI y refleja la recuperación de la actividad hospitalaria tras el impacto inicial de la pandemia por COVID-19 durante 2020. A pesar del incremento en el número total de implantes en España, este sigue siendo muy inferior a la media de la Unión Europea y persisten las diferencias entre las comunidades autónomas españolas.
Se presentan los datos correspondientes a los implantes de desfibrilador automático implantable (DAI) en España durante el año 2020.
Los datos provienen de los centros implantadores, que ...cumplimentaron voluntariamente una hoja de recogida de datos.
En 2020 se recibieron 7.056 hojas de implante, frente a las 7.106 comunicadas por Eucomed (European Confederation of Medical Suppliers Associations), lo que implica que se han recogido datos del 99% de los dispositivos implantados en España. La cumplimentación osciló entre el 99,8% en el campo «nombre del hospital implantador» y el 2,6% en la variable «hospital de referencia». Los hospitales que realizaron implantes de DAI y participaron en el registro fueron 173, un número similar al del año 2019 (172). La tasa total de implantes registrados fue 149/millón de habitantes (150 según Eucomed), lo que muestra una ligera disminución de los implantes en España en 2020 como consecuencia del impacto de la pandemia de la COVID-19. Esta reducción observada ha sido desigual entre las diferentes comunidades autónomas.
El Registro Español de Desfibrilador Automático Implantable del año 2020 recoge una mejora en la tasa de implantes comunicados y una reducción del número de implantes de DAI, lo que reflejaría la reducción de la actividad hospitalaria no relacionada con el tratamiento del paciente con COVID-19. De forma similar a los años previos, el número total de implantes en España sigue siendo muy inferior a la media de la Unión Europea, con un aumento en las diferencias entre las comunidades autónomas españolas.
We present the data corresponding to implantable cardioverter-defibrillator (ICD) implants in Spain in 2020.
The data in this registry were drawn from implantation centers, which voluntarily completed a data collection sheet.
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.
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.
Full English text available from:www.revespcardiol.org/en
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.
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