Pomeranian atRial flOw reguLatOr iN conGestive hEart failuRe (PROLONGER): Study protocol

Lewicki, Łukasz; Kosmalska, Katarzyna; Liedtke, Sebastian; Karwowski, Maciej; Siebert, Janusz; Sabiniewicz, Robert; Kiedrzyn, Jakub; Kot, Adrian; Szołkiewicz, Marek

doi:10.5603/cj.a2020.0137

Cited by 5 publications

(3 citation statements)

References 16 publications

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“…The Pomeranian atRial flOw reguLatOr iN conGestive hEart failuRe (PRO-LONGER) study was designed to establish invasive and noninvasive parameters capable of predicting a favourable response to AFR therapy in patients with HF. 17 Regardless of the type of atrial shunt used, it is crucial to determine which HF population will benefit most from it and assess the long-term patency rate of the device. 18 Future trials should also address issues related to post-implantation anti- Advances in device-based treatment of heart failure with preserved ejection fraction: evidence from clinical trials thrombotic therapy for IASD, the impact of right heart volume overload, and the potential increased risk of paradoxical stroke.…”

Section: Inter-atrial Shuntmentioning

confidence: 99%

“…The findings indicated that the AFR device in patients with HF was both feasible and safe and was associated with improved NYHA class, 6MWD, Kansas City Cardiomyopathy Questionnaire (KCCQ), PCWP, and N‐terminal pro‐B‐type natriuretic peptide (NT‐proBNP) in some but not all patients 16 (see Table 1 ). The Pomeranian atRial flOw reguLatOr iN conGestive hEart failuRe (PROLONGER) study was designed to establish invasive and noninvasive parameters capable of predicting a favourable response to AFR therapy in patients with HF 17 . Regardless of the type of atrial shunt used, it is crucial to determine which HF population will benefit most from it and assess the long‐term patency rate of the device 18 .…”

Section: Inter‐atrial Shuntmentioning

confidence: 99%

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Advances in device‐based treatment of heart failure with preserved ejection fraction: evidence from clinical trials

Wu,

Song,

et al. 2023

ESC Heart Failure

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Heart failure with preserved ejection fraction (HFpEF) is a group of clinical syndromes that exhibit a remarkably heterogeneous phenotype, characterized by symptoms and signs of heart failure, left ventricular diastolic dysfunction, elevated levels of natriuretic peptides, and an ejection fraction greater than or equal to 50%. With the aging of the population and the escalating prevalence of hypertension, obesity, and diabetes, the incidence of HFpEF is progressively rising. Drug therapy options for HFpEF are currently limited, and the associated high risk of cardiovascular mortality and heart failure rehospitalization significantly impact patients' quality of life and longevity while imposing a substantial economic burden on society. Recent research indicates that certain device‐based therapies may serve as valuable adjuncts to drug therapy in patients with specific phenotypes of HFpEF, effectively improving symptoms and quality of life while reducing the risk of readmission for heart failure. These include inter‐atrial shunt and greater splanchnic nerve ablation to reduce left ventricular filling pressure, implantable heart failure monitor to guide diuresis, left atrial pacing to correct interatrial dyssynchrony, cardiac contractility modulation to enhance cardiac calcium handling, as well as renal denervation, baroreflex activation therapy, and vagus nerve stimulation to restore the autonomic imbalance. In this review, we provide a comprehensive overview of the mechanisms and clinical evidence pertaining to these devices, with the aim of enhancing therapeutic strategies for HFpEF.

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Section: Inter-atrial Shuntmentioning

confidence: 99%

Section: Inter‐atrial Shuntmentioning

confidence: 99%

Advances in device‐based treatment of heart failure with preserved ejection fraction: evidence from clinical trials

Wu,

Song,

et al. 2023

ESC Heart Failure

View full text Add to dashboard Cite

show abstract

“…Although the improvements in clinical outcomes, such as 6MWD, NYHA class, and HRQoL are encouraging, they need to be validated by appropriately powered and, ideally, sham-controlled randomized trials. Several trials are now active, like the ALt FLOW US (NCT03523416) [ 32 ], RELIEVE-HF (NCT03499236) [ 33 ], and PROLONGER [ 34 ], recruiting patients with both HFrEF and HFpEF. Second, this meta-analysis is not based on individual patient data.…”

Section: Limitationsmentioning

confidence: 99%

Left atrium decompression devices across the spectrum of ejection fraction in heart failure: an updated systematic review and meta-regression analysis

et al. 2023

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Background In patients affected by heart failure (HF) with reduced ejection fraction (HFrEF), pharmacological treatments have been proven to alleviate symptoms and improve prognosis, while no treatment other than sodium-glucose co-transporter-2 inhibitors have demonstrated significant effects in HF with preserved ejection fraction (HFpEF). Left atrium decompression devices (LADd) have been recently investigated as a new interventional approach in patients with HFpEF. Objectives To assess the efficacy of LADd on soft endpoints in HF patients across the spectrum of ejection fraction. Methods PubMed and Web of Science were searched without restrictions from inception to 28 May 2022 to identify valuable articles. The studies that met the inclusion criteria were analyzed. The prespecified main outcomes were the change from baseline in 6-min walking distance (6MWD), NYHA class and health-related quality of life (HRQoL). Secondary outcomes were reduction in HF hospitalizations, echocardiographic, and hemodynamic parameters. Results Eleven studies, with a total of 547 patients, were included. LADd significantly improved 6MWD by 43.95 m (95% CI 29.64–58.26 m), decreased NYHA class by 0.93 (95% CI 1.20–0.67), and improved HRQoL questionnaire by 20.45 points (95% CI 13.77–27.14) with better results for all outcomes in patients with lower EFs. Conclusion The present meta-analysis suggests that LADd are favorable in improving 6MWD, NYHA class, and HRQoL in HF across a wide spectrum of ejection fraction, with better outcomes in patients with lower EFs. Trial registration CRD42022336077, URL: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=336077.

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Device-based percutaneous treatments to decompress the left atrium in heart failure with preserved ejection fraction

et al. 2022

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Heart failure with preserved ejection fraction (HFpEF) accounts for more than half of heart failure hospital admissions in the last years and is burdened by high mortality and poor quality of life. Providing effective management for HFpEF patients is a major unmet clinical need. Increase in left atrial pressure is the key determinant of pulmonary congestion, with consequent dyspnoea and exercise limitation. Evidence on benefits of medical treatment in HFpEF patients is limited. Thus, alternative strategies, including devices able to reduce left atrial pressure, through an interatrial communication determining a left–right shunt, were developed. This review aims to summarize evidence regarding the use of percutaneous interatrial shunting devices. These devices are safe and effective in improving hemodynamic and clinical parameters, including pulmonary capillary wedge pressure, 6-min walking distance, and New York Heart Association functional class. Data on cardiovascular mortality and re-hospitalization for heart failure are still scarce.

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Pomeranian atRial flOw reguLatOr iN conGestive hEart failuRe (PROLONGER): Study protocol

Cited by 5 publications

References 16 publications

Advances in device‐based treatment of heart failure with preserved ejection fraction: evidence from clinical trials

Advances in device‐based treatment of heart failure with preserved ejection fraction: evidence from clinical trials

Left atrium decompression devices across the spectrum of ejection fraction in heart failure: an updated systematic review and meta-regression analysis

Device-based percutaneous treatments to decompress the left atrium in heart failure with preserved ejection fraction

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