Papers by Massimo Grimaldi
Journal of clinical medicine, May 24, 2024
A notable increase in direct oral anticoagulant (DOAC) use has been observed in the last decade. ... more A notable increase in direct oral anticoagulant (DOAC) use has been observed in the last decade. This trend has surpassed the prescription of vitamin K antagonists (VKAs) due to the absence of the need for regular laboratory monitoring and the more favorable characteristics in terms of efficacy and safety. However, it is very common that patients on DOACs need an interventional or surgical procedure, requiring a careful evaluation and a challenging approach. Therefore, perioperative anticoagulation management of patients on DOACs represents a growing concern for clinicians. Indeed, while several surgical interventions require temporary discontinuation of DOACs, other procedures that involve a lower risk of bleeding can be conducted, maintaining a minimal or uninterrupted DOAC strategy. Therefore, a comprehensive evaluation of patient characteristics, including age, susceptibility to stroke, previous bleeding complications, concurrent medications, renal and hepatic function, and other factors, in addition to surgical considerations, is mandatory to establish the optimal discontinuation and resumption timing of DOACs. A multidisciplinary approach is required for managing perioperative anticoagulation in order to establish how to face these circumstances. This narrative review aims to provide physicians with a practical guide for DOAC perioperative management, addressing the most controversial issues.
European heart journal supplements, Apr 1, 2024
Journal of clinical medicine, Apr 23, 2024
In clinical practice, the number of patients treated with direct oral anticoagulants (DOACs) has ... more In clinical practice, the number of patients treated with direct oral anticoagulants (DOACs) has consistently increased over the years. Since anticoagulant therapy has been associated with an annual incidence of major bleeding (MB) events of approximately 2% to 3.5%, it is of paramount importance to understand how to manage anticoagulated patients with major or life-threatening bleeding. A considerable number of these patients' conditions necessitate hospitalization, and the administration of reversal agents may be imperative to manage and control bleeding episodes effectively. Importantly, effective strategies for reversing the anticoagulant effects of DOACs have been well recognized. Specifically, idarucizumab has obtained regulatory approval for the reversal of dabigatran, and andexanet alfa has recently been approved for reversing the effects of apixaban or rivaroxaban in patients experiencing life-threatening or uncontrolled bleeding events. Moreover, continuous endeavors are being made to develop supplementary reversal agents. In emergency scenarios where specific reversal agents might not be accessible, non-specific hemostatic agents such as prothrombin complex concentrate can be utilized to neutralize the anticoagulant effects of DOACs. However, it is paramount to emphasize that specific reversal agents, characterized by their efficacy and safety, should be the preferred choice when suitable. Moreover, it is worth noting that adherence to the guidelines for the reversal agents is poor, and there is a notable gap between international recommendations and actual clinical practices in this regard. This narrative review aims to provide physicians with a practical approach to managing specific reversal agents.
![Research paper thumbnail of [ANMCO/SIC Consensus statement on pulmonary arterial hypertension]](https://images.weserv.nl/?url=https%3A%2F%2Fa.academia-assets.com%2Fimages%2Fblank-paper.jpg&q=12&output=webp&max-age=110)
PubMed, Mar 1, 2024
Pulmonary hypertension (PH) is a frequent pathological condition worldwide, mainly secondary to c... more Pulmonary hypertension (PH) is a frequent pathological condition worldwide, mainly secondary to cardiovascular and respiratory diseases, with a poor prognosis. Pulmonary arterial hypertension (PAH) is a rare form that affects the arterial pulmonary vasculature. PH and PAH are characterized by non-specific symptoms and a progressive increase of pulmonary vascular resistance that results in progressive, sometimes irreversible, right ventricular dysfunction. In recent years, a growing medical and social commitment on this disease allowed more accurate diagnosis in shorter times. However, the gap between guidelines and clinical practice remains a challenge for all medical doctors involved in the disease management. Considering the needs to share and describe diagnostic and therapeutic pathways, to measure the results obtained and to address the economical and organizational problems of this disease, all involved figures should collaborate to improve its prognostic impact and health expenses. In this consensus document, the PH experts of the Italian Association of Hospital Cardiologists (ANMCO) together with those of the Italian Society of Cardiology (SIC), address 1) definition, classification and unmet needs of PH and PAH; 2) classification and characteristics of centers involved in the diagnosis and treatment of the disease; 3) proposal of organization of a diagnostic-therapeutic pathway, based on robust and recent scientific evidence.
PubMed, Mar 1, 2024
For over 40 years, clinical research has been one of the most important aims of the Italian Assoc... more For over 40 years, clinical research has been one of the most important aims of the Italian Association of Hospital Cardiologists (ANMCO), being an essential tool in pursuing promotion and fulfillment of good clinical practices in prevention, treatment and rehabilitation of cardiovascular diseases. Since 1992, with the creation of the Research Center (now part of the Heart Care Foundation), ANMCO is capable of independently and professionally managing all the aspects related to planning, management, and publication of the results of clinical studies. The other strength of ANMCO is the network built in Cardiology Departments on the whole territory of Italy, a human capital that allows ANMCO to deal with the new scientific challenges, in a context of profound changes in the social, economic, technological, and methodological setting. This document is based on the debate about the state of clinical research in Italy and the role of ANMCO in this setting that took place during the 2023 ANMCO States General.
PubMed, Apr 1, 2024
Scientific societies promote numerous activities, including the training of professionals. With t... more Scientific societies promote numerous activities, including the training of professionals. With the continuous growing of knowledge and the availability of new evidence in the cardiological field, the achievement and maintenance of knowledge and know-how is difficult. The evolving educational needs of professionals in cardiology have been analyzed during the 2023 ANMCO General States. Furthermore, the initiatives implemented to meet professionals' needs after the university medical training have been discussed. In this document, we report the main and most innovative training activities promoted by ANMCO, from distance training to simulation training, including courses for master's degree, training to and through clinical research and the potential role of teaching hospitals.
PubMed, Mar 1, 2024
Technological innovation provides easily accessible tools capable of simplifying healthcare proce... more Technological innovation provides easily accessible tools capable of simplifying healthcare processes. Notably, digital technology application in the cardiology field can improve prognosis, reduce costs, and lead to an overall improvement in healthcare. The digitization of health data, with the use of electronic health records and of electronic health files in Italy, represents one of the fields of application of digital technologies in medicine. The 2023 States General of the Italian Association of Hospital Cardiologists (ANMCO) provided an opportunity to focus attention on the potential benefits and critical issues associated with the implementation of the aforementioned digital tools, artificial intelligence, and telecardiology. This document summarizes key aspects that emerged during the event.
Journal of clinical medicine, Apr 5, 2024
Beta blockers (BBs) play a crucial role in enhancing the quality of life and extending the surviv... more Beta blockers (BBs) play a crucial role in enhancing the quality of life and extending the survival of patients with heart failure and reduced ejection fraction (HFrEF). Initiating the therapy at low doses and gradually titrating the dose upwards is recommended to ensure therapeutic efficacy while mitigating potential adverse effects. Vigilant monitoring for signs of drug intolerance is necessary, with dose adjustments as required. The management of older HF patients requires a case-centered approach, taking into account individual comorbidities, functional status, and frailty. Older adults, however, are often underrepresented in randomized clinical trials, leading to some uncertainty in management strategies as patients with HF in clinical practice are older than those enrolled in trials. The present article performs a scoping review of the past 25 years of published literature on BBs in older HF patients, focusing on age, outcomes, and tolerability. Twelve studies (eight randomized-controlled and four observational) encompassing 26,426 patients were reviewed. The results indicate that BBs represent a viable treatment for older HFrEF patients, offering benefits in symptom management, cardiac function, and overall outcomes. Their role in HF with preserved EF, however, remains uncertain. Further research is warranted to refine treatment strategies and address specific aspects in older adults, including proper dosing, therapeutic adherence, and tolerability.
Current problems in cardiology, Feb 1, 2024
Journal of Clinical Medicine, Aug 20, 2021
Flecainide is an IC antiarrhythmic drug (AAD) that received in 1984 Food and Drug Administration ... more Flecainide is an IC antiarrhythmic drug (AAD) that received in 1984 Food and Drug Administration approval for the treatment of sustained ventricular tachycardia (VT) and subsequently for rhythm control of atrial fibrillation (AF). Currently, flecainide is mainly employed for sinus rhythm maintenance in AF and the treatment of idiopathic ventricular arrhythmias (IVA) in absence of ischaemic and structural heart disease on the basis of CAST data. Recent studies enrolling patients with different structural heart diseases demonstrated good effectiveness and safety profile of flecainide. The purpose of this review is to assess current evidence for appropriate and safe use of flecainide, 30 years after CAST data, in the light of new diagnostic and therapeutic tools in the field of ischaemic and non-ischaemic heart disease.
Journal of Clinical Medicine, Apr 2, 2021
Transcatheter ablation was increasingly and successfully used to treat symptomatic drug refractor... more Transcatheter ablation was increasingly and successfully used to treat symptomatic drug refractory patients affected by supraventricular arrhythmias. Antiarrhythmic drug treatment still plays a major role in patient management, alone or combined with non-pharmacological therapies. Flecainide is an IC antiarrhythmic drug approved in 1984 from the Food and Drug Administration for the suppression of sustained ventricular tachycardia and later for acute cardioversion of atrial fibrillation and for sinus rhythm maintenance. Currently, flecainide is mostly used for sinus rhythm maintenance in atrial fibrillation (AF) patients without structural cardiomyopathy although recent studies enrolling different patient populations have demonstrated a good effectiveness and safety profile. How should we interpret the results of the CAST after the latest evidence? Is it possible to expand the indications of flecainide, and therefore, its use? This review aims to highlight the main characteristics of flecainide, as well as its optimal clinical use, delineating drug indications and contraindications and appropriate monitoring, based on the most recent evidence.
Minerva cardiology and angiology, Feb 1, 2023
BACKGROUND Catheter ablation (CA) of atrial fibrillation (AF) is used routinely to establish rhyt... more BACKGROUND Catheter ablation (CA) of atrial fibrillation (AF) is used routinely to establish rhythm control. There is mounting evidence that CA procedures should be performed during continuous oral anticoagulation and direct oral anticoagulants (DOACs) are considered the first anticoagulation strategy. Few real-life data are now available and even less in the Italian panorama. METHODS IRIS is an Italian multicenter, non-interventional, prospective study which will be enrolled consecutive AF patients eligible for CA and treated with Rivaroxaban; patients in treatment with Rivaroxaban proceeded directly to CA while Rivaroxaban-naive patients were scheduled for CA after 4 weeks of uninterrupted anticoagulation unless the exclusion of atrial thrombi. Rivaroxaban was uninterrupted or shortly uninterrupted (<24 hours) prior CA, in line with routinely practice of each operator. Patients will be followed on continuous anticoagulation for 1 month after the ablation. The primary efficacy outcome is the cumulative incidence of all-cause death and systemic embolism while the primary safety outcome is the incidence of major bleeding events. The secondary outcomes are represented by non-major bleeding events. All events must be occurred within the first 30 days after the procedure. RESULTS 250 patients are expected to be enrolled and the study is estimated to be completed by the end of 2022. Up to now 56 patients have been enrolled. CONCLUSIONS This study is the first large Italian prospective study on the management of Rivaroxaban in patients undergoing CA of AF. It aims to depict a comprehensive view of anticoagulation strategy prior CA in several Italian electrophysiology labs.
PubMed, Feb 1, 2024
It is well established that gender strongly influences cardiovascular risk factors, playing a cru... more It is well established that gender strongly influences cardiovascular risk factors, playing a crucial role in cardiovascular prevention, clinical pathways, diagnostic approach and treatment. Beyond the sex, which is a biological factor, gender entails a socio-cultural condition that impacts access and quality of care due to structural and institutional barriers. However, despite its great importance, this issue has not been adequately covered. Indeed sex and gender differences scarcely impact the clinical approach, creating a lot of disparities in care and outcomes of patients. Therefore, it becomes essential to increase the awareness of the importance of sex and gender influences on cardiovascular diseases. Moreover, new strategies for reducing disparities should be developed. Importantly, these differences should be taken into account in guideline recommendations. In this regard, it is crucial to include a greater number of women in clinical trials, since they are currently underrepresented. Furthermore, more women should be involved as member of international boards in order to develop recommendations and guidelines with more attention to this important topic.The aim of this ANMCO position paper is to shed light on gender differences concerning many cardiovascular drugs in order to encourage a more personalized therapeutic approach.
Journal of Cardiovascular Electrophysiology, Nov 26, 2023
Journal of Arrhythmia, Apr 28, 2022
PubMed, Sep 1, 2021
This critical review illustrates the pathophysiological aspects and available scientific evidence... more This critical review illustrates the pathophysiological aspects and available scientific evidence about cardiac contractility modulation therapy. A useful algorithm dealing with the essential decisional knots to consider for device implantation in patients with heart failure in NYHA class >II and ejection fraction ≤45% is presented. The present review paves the way for the development of an Italian registry aiming at analyzing the characteristics of implanted patients based on a multiparametric approach, including cardiac biomarkers, to identify clinical profiles and predictors of response to therapy. The "Answers and Questions" section provides useful insights into pathophysiology, technical specifications, clinically relevant scenarios and future perspectives.
Journal of Cardiovascular Electrophysiology, Jun 21, 2017
Background. Pulmonary vein (PV) isolation is the cornerstone of catheter ablation in patients wit... more Background. Pulmonary vein (PV) isolation is the cornerstone of catheter ablation in patients with atrial fibrillation (AF). "Single shot" ablation devices have been recently engineered. Objectives. We report on the safety and efficacy of a novel ablation catheter for PV isolation in patients with AF. . One hundred-eighty consecutive patients (58±10 years, 125 males, 31% with structural heart disease) referred for paroxysmal (140) or persistent (40) AF underwent PV isolation by an open-irrigated mapping and radiofrequency (RF) decapolar ablation catheter in 7 centers. Ablation was guided by electroanatomic mapping allowing RF energy delivery in the antral region of PVs from 10 irrigated electrodes simultaneously. Results. Mean overall procedure time was 113±53 min with a mean fluoroscopy time of 13.1±8.4 min. The use of a pre-ablation PV imaging related to a significant reduction in fluoroscopy time (from 14.7±9.7 to 8.7±6.6, p<0.001). Mean ablation time was 12.5±5.1 min, 98% of the targeted veins were isolated with a mean of 23.4±6.3 RF pulses per patient. In only four (2.2%) patients a single point ablation strategy was required to achieve PV isolation. One groin hemathoma and one PV stenosis were reported. During a mean follow-up of 13.9 ± 8.2 months 38/140 (27%) patients with paroxysmal AF and 12/40 (30%) patients with persistent AF had an atrial arrhythmia relapse (p=0.671) Conclusions. In this multicenter registry, irrigated multi-electrode RF ablation resulted feasible, achieving a high rate of isolated PVs. Procedural and fluoroscopy times and success rates were comparable with other techniques with a low complication rate.
PubMed, Aug 1, 2023
This review illustrates the pathophysiological aspects and available scientific evidence on molec... more This review illustrates the pathophysiological aspects and available scientific evidence on molecular mechanisms about cardiac contractility modulation (CCM) therapy. The main advances in understanding the effect of this electrical therapy at cellular level in the heart are critically discussed in light of the data from clinical trials supporting the use of CCM therapy in patients with heart failure across a wide range of left ventricular ejection fraction values. This electrical therapy triggers a physiological cellular response leading to an improvement of cardiac performance and reverse ventricular remodeling, with no increase in oxygen consumption. The present review deals with the new potential applications of CCM for patients with chronic heart failure and paves the way for the development of a longitudinal Italian registry of patients implanted with this cardiac device.
Heart Rhythm, May 1, 2023
Uploads
Papers by Massimo Grimaldi