Cardiac resynchronization therapy in continuous flow left ventricular assist device recipients: A systematic review and meta-analysis from ELECTRAM investigators

Introduction: Whether cardiac resynchronization therapy (CRT) continues to augment left ventricular remodeling in patients with the continuous-flow left ventricular assist device (cf-LVAD) remains unclear. Methods: We performed a systematic review and meta-analysis of all clinical studies examining the role of continued CRT in end-stage heart failure patients with cf-LVAD reporting all-cause mortality, ventricular arrhythmias, and ICD shocks. Mantel-Haenszel risk ratio (RR) random-effects model was used to summarize data. Results: Eight studies (7 retrospective and 1 randomized) with a total of 1,208 unique patients met inclusion criteria. There was no difference in all-cause mortality (RR 1.08, 95% CI 0.86-1.35, p = 0.51, I2=0%), all-cause hospitalization (RR 1.01, 95% CI 0.76-1.34, p = 0.95, I2=11%), ventricular arrhythmias (RR 1.08, 95% CI 0.83-1.39, p = 0.58, I2 =50%) and ICD shocks (RR 0.87, 95% CI 0.57-1.33, p = 0.52, I2 =65%) comparing CRT versus non-CRT. Subgroup analysis demonstrated significant reduction in ventricular arrhythmias (RR 0.76, 95% CI 0.64-0.90, p = 0.001) and ICD shocks (RR 0.65, 95% CI 0.44-0.97, p = 0.04) in CRT on group versus CRT off group. Conclusion: CRT was not associated with a reduction in all-cause mortality or increased risk of ventricular arrhythmias and ICD shocks compared to non-CRT in cf-LVAD patients. It remains to be determined which subgroup of cf-LVAD patients benefit from CRT.The findings of our study are intriguing, and therefore,larger studies in a randomized prospective manner should be undertaken to address this specifically

Active Implantable cardioverter-defibrillators in Continuous-flow Left Ventricular Assist Device Recipients

Introduction Implantable cardioverter-defibrillator (ICD) in patients with heart failure with reduced ejection fraction reduces mortality secondary to malignant arrhythmias. Whether end-stage heart failure (HF) with continuous-flow left ventricular assist device (cf-LVAD) derive similar benefits remains controversial. Methods We performed a systematic literature review and meta-analysis of all published studies that examined the association between active ICDs and survival in advanced HF patients with cfLVAD. We searched PubMed, Medline, Embase, Ovid, and Cochrane for studies reporting the association between ICD and all-cause mortality in advanced HF patients with cfLVAD. Mantel-Haenszel risk ratio (RR) random-effects model was used to summarize data. Results Ten studies (9 retrospective and one prospective) with a total of 7,091 patients met inclusion criteria. There was no difference in all-cause mortality (RR 0.84, 95% CI 0.65–1.10, p=0.20, I2 =62.40%), likelihood of survival to transplant (RR 1.07, 95% CI 0.98–1.17, p= 0.13, I2 =0%), RV failure (RR 0.74, 95% CI 0.44–1.25, p = 0.26, I2 =34%) between Active ICD and inactive/no ICD groups, respectively. Additionally, 27.5% received appropriate ICD shocks, while 9.5% received inappropriate ICD shocks. No significant difference was observed in terms of any complications between the two groups. Conclusions All-cause mortality, the likelihood of survival to transplant, and worsening RV failure were not significantly different between active ICD and inactive/no ICD in cf-LVAD recipients. A substantial number of patients received appropriate ICD shocks suggesting a high-arrhythmia burden. The risks and benefits of ICDs must be carefully considered in patients with cf-LVAD

Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF).

AIMS Pulsed field ablation (PFA) is a novel atrial fibrillation (AF) ablation modality that has demonstrated preferential tissue ablation, including no oesophageal damage, in first-in-human clinical trials. In the MANIFEST-PF survey, we investigated the 'real world' performance of the only approved PFA catheter, including acute effectiveness and safety-in particular, rare oesophageal effects and other unforeseen PFA-related complications. METHODS AND RESULTS This retrospective survey included all 24 clinical centres using the pentaspline PFA catheter after regulatory approval. Institution-level data were obtained on patient characteristics, procedure parameters, acute efficacy, and adverse events. With an average of 73 patients treated per centre (range 7-291), full cohort included 1758 patients: mean age 61.6 years (range 19-92), female 34%, first-time ablation 94%, paroxysmal/persistent AF 58/35%. Most procedures employed deep sedation without intubation (82.1%), and 15.1% were discharged same day. Pulmonary vein isolation (PVI) was successful in 99.9% (range 98.9-100%). Procedure time was 65 min (38-215). There were no oesophageal complications or phrenic nerve injuries persisting past hospital discharge. Major complications (1.6%) were pericardial tamponade (0.97%) and stroke (0.4%); one stroke resulted in death (0.06%). Minor complications (3.9%) were primarily vascular (3.3%), but also included transient phrenic nerve paresis (0.46%), and TIA (0.11%). Rare complications included coronary artery spasm, haemoptysis, and dry cough persistent for 6 weeks (0.06% each). CONCLUSION In a large cohort of unselected patients, PFA was efficacious for PVI, and expressed a safety profile consistent with preferential tissue ablation. However, the frequency of 'generic' catheter complications (tamponade, stroke) underscores the need for improvement

EHRA expert consensus statement on arrhythmic mitral valve prolapse and mitral annular disjunction complex in collaboration with the ESC Council on valvular heart disease and the European Association of Cardiovascular Imaging endorsed cby the Heart Rhythm Society, by the Asia Pacific Heart Rhythm Society, and by the Latin American Heart Rhythm Society.

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Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study

Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for ~1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF.Peer reviewe