DOI: 10.19102/icrm.2024.15083
PEDDI PAVANI, MBBS,1 OLUSEGUN ABIOLA OLANREWAJU, MBBS,2 RAJA SUBHASH SAGAR, MBBS,3 MONIKA BAI, MBBS,4 JAI CHAND, MBBS,5 VISHAL BHATIA, MBBS,5 FNU SAGAR, MBBS,6 FNU KARISHMA, MBBS,7 HAMZA ISLAM, MBBS,8 AMAN KUMAR, MBBS,7 FNU VERSHA, MBBS,4 RABIA ISLAM, MBBS,8 and TAHA NADEEM, MBBS9
1Department of Surgery, Kurnool Medical College, Kurnool, India
2Department of Medicine, Stavropol State Medical University, Stavropol, Russia
3Department of Medicine, Liaquat University of Medical and Health Sciences, Jamshoro, Pakistan
4Department of Medicine, Peoples University of Medical and Health Sciences for Women, Nawabshah, Pakistan
5Department of Medicine, Khairpur Medical College, Khairpur, Pakistan
6Department of Medicine, Bahria University Medical and Dental College, Karachi, Pakistan
7Department of Medicine, Ghulam Muhammad Mahar Medical College, Sukkur, Pakistan
8Department of Medicine, Punjab Medical College, Faisalabad, Pakistan
9Department of Medicine, Allama Iqbal Medical College, Lahore, Pakistan
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ABSTRACT. Atrial fibrillation (AF) affects around 33 million people worldwide, rendering it a common cardiac arrhythmia. Catheter ablation (CA) has evolved as a leading therapeutic intervention for symptomatic AF. This umbrella review systematically evaluates existing systematic reviews and meta-analyses to assess the safety, efficacy, and potential of high-power, short-duration (HPSD) ablation as an alternative therapy option for AF. A thorough exploration was undertaken across PubMed, the Cochrane Library, and Embase to identify pertinent studies for inclusion in this umbrella review. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) method was employed to assess the overall certainty of the evidence comprehensively, and the quality of the incorporated reviews was meticulously evaluated through use of the AMSTAR 2 tool, the Cochrane Collaboration tool, and the Newcastle–Ottawa scale. In this study, we initially identified 35 systematic reviews and meta-analyses, narrowing them down to a final selection of 11 studies, which collectively integrated data from 6 randomized controlled trials and 26 observational studies. For primary efficacy outcomes, the HPSD approach led to a non-significant decrease in the risk of atrial tachyarrhythmia recurrence (risk ratio [RR], 0.88; 95% confidence interval [CI], 0.70–1.12; I2 = 90%; P = .31) and a significantly reduced risk of AF recurrence (RR, 0.53; 95% CI, 0.42–0.67; I2 = 0%; P < .00001) compared to the low-power, long-duration (LPLD) approach. In terms of primary safety outcomes, the HPSD approach significantly reduced the risk of esophageal thermal injury (ETI) (RR, 0.71; 95% CI, 0.61–0.83; I2 = 0%; P < .00001) and facilitated a non-significant decrease in the risk of other major complications (RR, 0.87; 95% CI, 0.73–1.03; I2 = 0%; P = .10). In conclusion, HPSD therapy is safer and more effective than LPLD therapy, facilitating decreased AF recurrence rates along with reductions in ETI, total procedure duration, ablation number, ablation time, fluoroscopy time, and acute pulmonary vein reconnection.
KEYWORDS. Atrial fibrillation, high-power short duration, low-power long duration, radiofrequency ablation, short duration.
The authors report no conflicts of interest for the published content. No funding information was provided.
Manuscript received February 22, 2024. Final version accepted March 15, 2024.
Address correspondence to: Aman Kumar, Department of Medicine, Ghulam Muhammad Mahar Medical College, PV2C+GX7, GMC Rd., Sukkur, Sindh 65200, Pakistan. Email: ak03336577700@gmail.com.
Globally, approximately 33 million individuals suffer from atrial fibrillation (AF), the most prevalent abnormal heartbeat observed in clinical practice.1 It is frequently associated with complications such as strokes, heart failure, and an increased risk of mortality. This disorder is a significant concern in medicine because of its widespread prevalence and link to serious health problems.1 Catheter ablation (CA) for AF has progressed from a trial approach to the most effective therapy for those with symptoms. This change is supported by positive clinical outcomes data, demonstrating that this treatment has potential effects for patients suffering from AF-related issues.2
Historically, doctors employed radiofrequency (RF) energy to induce low-power, long-duration (LPLD) lesions in the heart during CA, guided by parameters such as the force–time integral.3 However, the optimum ablation settings for safe long-term pulmonary vein isolation (PVI) are still being investigated. There is an increasing interest in creating high-power, short-duration (HPSD) lesions, which appear to shorten the procedure and fluoroscopy time and potentially lower the risk of adverse effects by limiting heat transmission to nearby tissues and causing less damage.4
Many ablation centers have traditionally used the LPLD approach to generate lesions for PVI.5 This strategy seeks to reduce the likelihood of problems, such as cardiac tamponade and pulmonary vein stenosis. Typically, these settings require applying 25–40 W of power for 20–40 s at each location, with a contact force (CF) of 10–20 g.6 However, there needs to be a clear understanding of what defines HPSD ablation, with research indicating that power levels range from 50–90 W and durations vary across investigations.7 Considering the gap in the literature and universal implementation of HPSD instead of LPLD, we performed an umbrella review of all available systematic reviews and meta-analyses to determine the safety, effectiveness, and potential of this alternate therapy option for HPSD ablation.
This comprehensive review adhered to the guidelines outlined in the Preferred Reporting Items for Systematic Reviews and Meta-analyses and the Cochrane Collaboration Handbook.8,9
Search strategy
The search strategy was executed across various databases, including PubMed, the Cochrane Library, and Embase, ensuring a thorough exploration of the scientific literature. An extensive array of keywords and Medical Subject Headings was carefully curated to guarantee inclusivity. Encompassing facets such as “radiofrequency ablation,” “high-power,” “short-duration,” “low-power,” “long-duration,” “atrial fibrillation treatment,” “efficacy,” “safety profiles,” “catheter ablation,” “heart rhythm disorders,” and “cardiac arrhythmias,” these keywords were strategically combined using the Boolean operators “AND” and “OR” to both refine and broaden the search. A summary of the detailed search strategy, including specific combinations of keywords and operators, can be found in Supplementary Table S1. To uphold the integrity of the process and minimize potential selection bias, two independent researchers searched the literature, resolving disagreements through consensus. A third researcher was engaged in cases of persistent discrepancies to ensure resolution and reliability.
Study inclusion and exclusion criteria
Inclusion criteria
This umbrella review centered on systematically executed, high-quality reviews and meta-analyses, aiming to investigate the comparative efficacy of HPSD and LPLD for the management of AF. The encompassed studies targeted adult participants aged ≥18 years conclusively diagnosed with AF. The review incorporated studies exploring HPSD RF ablation (RFA) as a therapeutic approach for AF, including meta-analyses and systematic reviews directly comparing the effectiveness and safety of HPSD versus LPLD in treating AF. Inclusion criteria extended to studies providing valuable insights into pertinent clinical outcomes, such as atrial tachyarrhythmias (ATAs), AF recurrence, esophageal thermal injury (ETI), and other significant complications.
Exclusion criteria
This umbrella review excluded primary studies, conference abstracts, letters, editorials, and reviews failing to meet the stringent criteria for systematic reviews and meta-analyses. Additionally, reviews focusing on pediatric populations (participants aged <18 years) or using animal models were expressly omitted. Studies investigating treatments unrelated to HPSD or LPLD for AF were not considered. Furthermore, reviews that did not directly compare HPSD with LPLD within AF were excluded. This comprehensive review rigorously maintained exclusion criteria, ensuring the exclusion of studies lacking relevant clinical outcomes or reporting incomplete data.
Data extraction and definitions
Relevant information was extracted during the data-extraction process, encompassing publication details, study attributes, participant features, ablation procedure strategies, and clinical outcomes. Primary efficacy outcomes included ATA and AF recurrence post-blanking (2 or 3 months post-ablation), depending on the studies included, whereas primary safety outcomes were ETI and other major complications. Secondary outcomes included first-pass pulmonary vein isolation (FPI), acute pulmonary vein reconnection (PVR), procedural time, PVI number, ablation number, and fluoroscopy time. High power was defined as >40 W, and the extracted data were separated into the high-power (HP) group and the low-power (LP) group.
ATA recurrence was defined by symptomatic or asymptomatic ATAs lasting >30 s after the blanking period post-ablation. ETI was defined as esophageal thermal injury brought on by ablation, evaluated through endoscopy and/or magnetic resonance imaging late gadolinium enhancement. FPI was defined as the first-pass RF-delivery PVI achievement rate, and acute PVR was defined as the pulmonary vein electrical reconnection rate after the first-pass CA. Ablation number refers to the count or quantity of RFAs performed during the procedure. Procedural time was defined as the time between the beginning of anesthesia and removal of all sheaths. In contrast, fluoroscopy time was the total time spent using a fluoroscope during the procedure.
Assessment of the risk of bias
The methodological quality of the incorporated reviews and meta-analyses underwent a meticulous evaluation by two independent investigators using the AMSTAR 2 tool. This tool comprehensively addresses 16 essential methodological domains, offering a nuanced assessment. The overall quality of the studies emerged was categorized as either high, moderate, low, or critically low, guided by established criteria.10
We employed the Cochrane Collaboration risk-of-bias tool to assess the risk of bias inherent in randomized controlled trials (RCTs) included in individual meta-analyses.11 This comprehensive tool systematically evaluates eight potential sources of bias, including random sequence generation, allocation concealment, blinding of participants and evaluators, outcome assessments, and handling of incomplete outcome data. The quality of observational studies underwent scrutiny by application of the Newcastle–Ottawa scale. This assessment encompassed crucial domains, such as study design, participant selection, blinding, outcome reporting, and other pertinent parameters, ensuring a comprehensive evaluation of their robustness.12
The certainty of evidence and the strength of recommendations derived from meta-analyses underwent rigorous scrutiny using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) method.13 This method categorizes evidence into four tiers: “high,” “moderate,” “low,” and “very low.” Initiated at the “high” level, the GRADE assessment underwent subsequent adjustments based on identified risks of bias, results inconsistency, evidence indirectness, imprecision, or publication bias. Two researchers conducted the GRADE assessment independently for each study’s primary outcomes, engaging in discussions and reaching agreements to address any disparities.
Statistical analysis
All statistical analyses were meticulously executed, using STATA 16 and Review Manager version 5.4. Categorical outcomes were assessed through the computation of risk ratios (RRs) accompanied by 95% confidence intervals (CIs), employing the DerSimonian and Laird random-effects model. Mean differences were calculated for continuous data, with statistical significance in two-sided tests set at P < .05. The I2 statistic was applied to scrutinize heterogeneity among study associations.14 Rigorous sensitivity analyses were performed to assess the robustness of summary estimates and pinpoint any singular study significantly contributing to heterogeneity, notably when heterogeneity exceeded 75%. Egger’s regression asymmetry test was applied to primary outcomes, investigating evidence of small-study effects,15 where P < .05 indicated such effects. “P-hacking”16 and evaluating publication bias were conducted through funnel plots of primary outcomes.
Regarding ethical considerations and conflicts of interest, this umbrella review exclusively relies on previously published systematic reviews and meta-analyses, eliminating the need to collect or analyze primary data from human participants. Consequently, ethical review board approval and patient consent did not apply to this study. The authors unequivocally assert that no conflicts of interest, whether financial or non-financial, could sway the impartiality or interpretation of the findings in this umbrella review. The entire research process and outcomes remain impervious to external affiliations or funding sources, ensuring a commitment to unbiased reporting.
Study selection
Initially, a total of 35 systematic reviews and meta-analyses were identified, and subsequent elimination of duplicate entries was undertaken. Upon exhaustive scrutiny of the complete texts, a final selection of 11 systematic reviews and meta-analyses17–27 was made. These chosen studies comprehensively compiled data from 6 RCTs and 26 observational studies, encompassing prospective and retrospective cohort studies. Table 1 briefly outlines the key characteristics of the integrated meta-analyses within the scope of this review.
Risk of bias of included studies
The methodological quality assessments for the 11 systematic reviews and meta-analyses, appraised through the AMSTAR 2 tool, are delineated in Supplementary Table S2. Each of the 11 studies was assigned a moderate-quality rating. The GRADE assessment, detailed in Supplementary Table S3, indicated a diverse range of certainty levels within the reviews employed for our study, encompassing evaluations from low to high. Individual RCTs underwent a comprehensive quality evaluation using the Cochrane risk-of-bias tool, revealing trials characterized by a moderate to low risk of bias, as illustrated in Supplementary Figure S1. Furthermore, the quality appraisal of observational studies was meticulously executed using the Newcastle–Ottawa scale, exposing a spectrum of quality across the studies included in the analysis, extending from fair to good, as expounded in Supplementary Table S4.
Supplementary Figure S1: Cochrane risk-of-bias assessment for individual randomized controlled trials. |
Synthesis of results
Primary efficacy outcomes
The primary efficacy outcomes encompassed the recurrence of ATAs and AF. Across 10 out of 11 studies, data on ATA recurrence were reported. The pooled analysis indicated a non-significant decrease in the risk of ATA recurrence associated with the HPSD approach compared to the LPLD approach (RR, 0.88; 95% CI, 0.70–1.12; I2 = 90%; P = .31), as illustrated in Figure 1. In response to the notable in-study heterogeneity, a leave-one-out sensitivity analysis was conducted, revealing that no individual study was the cause of the observed high heterogeneity. The data about AF recurrence, sourced from 3 out of the 11 studies, indicated through pooled analysis that the employment of the HPSD approach was associated with a significantly reduced risk of AF recurrence compared to the LPLD approach (RR, 0.53; 95% CI, 0.42–0.67; I2 = 0%; P < .00001), as depicted in Figure 2.
Figure 1: Recurrence of atrial tachyarrhythmias. This figure presents a comprehensive analysis of the recurrence of atrial tachyarrhythmias after radiofrequency ablation, revealing a non-significant decrease in the risk of atrial tachyarrhythmia recurrence associated with the high-power, short-duration approach compared to the low-power, long-duration approach. Abbreviations: CI, confidence interval; HPSD, high-power, short-duration; IV, inverse variance; LPLD, low-power, long-duration; RR, risk ratio; SE, standard error. |
Figure 2: Recurrence of atrial fibrillation following ablation. This figure illustrates a pooled analysis that reveals a statistically significant reduction in the risk of atrial fibrillation recurrence associated with the high-power, short-duration approach compared to the low-power, long-duration approach. Abbreviations: CI, confidence interval; HPSD, high-power, short-duration; IV, inverse variance; LPLD, low-power, long-duration; RR, risk ratio; SE, standard error. |
Primary safety outcomes
The primary safety endpoints encompassed ETI and other major complications. Data regarding ETI were provided by 9 out of the 11 studies, and the aggregated analysis demonstrated that use of the HPSD approach was associated with a significantly reduced risk of ETI compared to the LPLD approach (RR, 0.71; 95% CI, 0.61–0.83; I2 = 0%; P < .00001), as depicted in Figure 3. The data pertaining to other major complications, sourced from 7 out of the 11 studies, showed through pooled analysis that the adoption of the HPSD approach was associated with a non-significant decrease in the risk of other major complications compared to the LPLD approach (RR, 0.87; 95% CI, 0.73–1.03; I2 = 0%; P = .10), as illustrated in Figure 4.
Figure 3: Risk of esophageal thermal injury following ablation. This figure presents an aggregated analysis that reveals a statistically significant reduction in the risk of esophageal thermal injury associated with the high-power, short-duration approach compared to the low-power, long-duration approach. Abbreviations: CI, confidence interval; HPSD, high-power, short-duration; IV, inverse variance; LPLD, low-power, long-duration; RR, risk ratio; SE, standard error. |
Figure 4: Risk of other major complications following ablation. This figure elucidates the pooled analysis investigating the incidence of other major complications following radiofrequency ablation. The pooled analysis portrays that treatment with the high-power, short-duration approach was associated with a non-significant decrease in the risk of other major complications compared to treatment with the low-power, long-duration approach. Abbreviations: CI, confidence interval; HPSD, high-power, short-duration; IV, inverse variance; LPLD, low-power, long-duration; RR, risk ratio; SE, standard error. |
Secondary outcomes
The secondary outcomes included FPI, total procedure time, ablation time, ablation number, fluoroscopy time, and acute PVR. The results of the analysis of secondary outcomes are summarized in Table 2. The pooled analysis revealed that treatment with the HPSD approach was associated with a significantly increased risk of FPI and a significantly decreased risk of acute PVR. Furthermore, the analysis revealed that treatment with the HPSD approach was associated with a significantly reduced total procedure time, fluoroscopy time, and ablation time compared to the LPLD approach, along with a non-significantly reduced ablation number.
P-hacking, publication bias, and small-study effect
The absence of evidence indicating P-hacking in our study signifies that the results were not manipulated to achieve a predetermined outcome. In scrutinizing the primary outcomes, we conducted a thorough analysis with sufficient studies, facilitating a comprehensive funnel plot analysis. Our findings disclosed a symmetrical distribution of data points in the funnel plots for each primary outcome. The observed symmetry in the data implies the non-existence of publication bias, as demonstrated in Supplementary Figure S2. Furthermore, we employed Egger’s regression asymmetry test to assess small-study effects for the primary outcomes, with values for each outcome exceeding 0.05. This indicates a lack of substantial evidence supporting small-study effects. The results of Egger’s regression asymmetry test are briefly outlined in Table 3.
Supplementary Figure S2: Funnel plots. A: Recurrence of atrial tachyarrhythmias. B: Esophageal thermal injury. C: Other major complications. The funnel plots showed no risk of publication bias. |
In recent decades, percutaneous CA has developed as an essential treatment option for AF, with the goal of restoring and maintaining normal sinus rhythm. PVI is now recognized as the cornerstone of catheter-based ablation therapies for the treatment of paroxysmal and early persistent AF.28,29 Recent studies have looked into using greater RF energy output with shorter pulses in AF ablation techniques to improve safety and create longer-lasting lesions.30 This HPSD ablation technique uses higher RF power levels (45–50 W) for shorter durations (5–15 s) per RF energy application instead of the traditional method of lower power (25–30 W) for longer application durations (30–60 s).31 The HPSD approach uses a short burst of RF energy to heat up and destroy specific tissue in the atrium and avoids heating nearby tissues, such as the esophagus, which lowers the risk of damage to other surrounding tissues.32
Our comprehensive umbrella review of 11 systematic reviews and meta-analyses comparing the HPSD method to LPLD sought to identify clinical outcomes that persisted across both procedures. Our primary focus was on the recurrence of ATAs, AF, ETI, and other significant complications. Regarding efficacy outcomes, the study revealed that HPSD was related to a decrease in the probability of ATA recurrence, although this finding was non-significant; nevertheless, the reduced risk of AF recurrence was substantial enough to evaluate this therapy over LPLD clinically. Our findings markedly differ from those of a recent meta-analysis conducted by Li et al.26 Their analysis encompassed ATA and AF recurrence rates at 6-month and 12-month intervals post-surgery, collated from 18 studies. Initially, there was no statistically significant difference in AF recurrence rates between the HPSD and LPLD groups (RR, 1.11; 95% CI, 0.96–1.28; I2 = 45%; P = .16). However, with an extended follow-up period of 12 months, a notable divergence emerged. HPSD groups exhibited greater rates of both AF and ATA recurrence compared to conventional groups (for freedom from AF: RR, 1.17; 95% CI, 1.07–1.27; I2 = 32%; P = .0003) (for freedom from AT: RR, 1.11; 95% CI, 1.05–1.17; I2 = 32%; P < .0001). This suggests that the therapeutic benefits of HPSD may become more pronounced with longer-term patient follow-up. Nevertheless, our comprehensive analyses, incorporating all available literature to date, consistently indicate that HPSD exhibits greater clinical efficacy over LPLD, specifically in terms of AF recurrence rather than ATA recurrence.
In the context of safety outcomes, our investigation demonstrated that HPSD therapy exhibited a significantly reduced risk of ETI. However, the reduction in major complications, while notable, did not reach statistical significance, thus requiring further investigation to establish its enhanced safety profile and decreased adverse event risks. A recent study conducted in 2022 by Khanra et al.18 yielded similar observations in their pooled analysis. They reported a lower incidence and severity of ETI in the HPSD group. However, the differences did not reach statistical significance. Notably, despite comparable maximum esophageal temperatures between the two groups, the HPSD group experienced significantly fewer esophageal temperature alerts, indicating a potential advantage in terms of safety.
Our study systematically investigated several other important outcomes, consisting of FPI, total procedure time, ablation time, ablation number, fluoroscopy time, and acute PVR. The analysis revealed a noteworthy increase in the incidence of FPI, coupled with significant reductions in total procedure time, ablation number, ablation time, fluoroscopy time, and acute PVR. These findings collectively underscore the statistical significance supporting the superior efficacy of HPSD therapy compared to LPLD in the management of patients with AF. There are two phases involved in the thermal damage caused by an irrigated RFA catheter tip: resistive and conductive. When using HP settings, most RF energy is absorbed in the first 1–3 mm of tissue around the electrode tip of the ablation catheter.33–35 By increasing the resistive heating’s rim size to >50°C, HPSD ablation encourages the development of long-lasting lesions. Because the antral thickness of these lesions is often <4 mm, their bigger dimensions and shallower depth make them especially suitable for PVI.34 This feature of HPSD ablation helps to reduce the risk of extracardiac damage, improve PVI, and promote contiguous ablation lesions.35 Interestingly, HPSD protocols depend less on the conductive phase of heating, which is consistent with our findings of decreased acute PVR and elevated FPI.
Our study has several strengths and some limitations. In terms of strengths, this is the first umbrella review ever conducted on this topic, reducing uncertainties and gaps between previous meta-analyses’ findings. Second, we performed an Egger’s regression test to demonstrate that no publication bias was reported. In terms of limitations, different systematic reviews and meta-analyses have used a variety of evidence-synthesis procedures, such as quality-evaluation tools and meta-analytic methodologies, which may lead to uncertainty. Second, high heterogeneity in some outcomes may be attributed to the diverse methodology, inclusion and exclusion criteria, patient population, study design, and outcome measures employed in all systematic reviews and meta-analyses.
In conclusion, HPSD therapy emerges as a safer and more successful alternative to traditional LPLD therapy. This method not only reduces AF recurrence rates significantly but also mitigates undesirable consequences, such as ETI. Furthermore, there are considerable improvements in many procedural elements, such as total procedure duration, ablation number, ablation time, fluoroscopy time, and acute PVR. To support these findings, future research should incorporate more extensive clinical studies with more significant sample numbers. This method will give a more solid foundation for evidence-based findings while also improving our understanding of the comparative efficacy and safety of HPSD therapy in AF management.