Randomized comparison of balloon aortic valvuloplasty performed with or without rapid cardiac pacing: results from the PNP randomized study (Pacing vs No-Pacing)

Obiettivo Studio pilota sul confronto di efficacia e sicurezza della tecnica di valvuloplastica aortica con pallone (BAV) eseguita con o senza pacing rapido (PR) ventricolare attraverso un pacemaker temporaneo. Calcolo del campione di popolazione da arruolare in uno studio randomizzato più ampio. Contesto La tecnica della BAV non è standardizzata. Metodi Cento pazienti consecutivi sono stati randomizzati 1:1 tra BAV eseguita con o senza PR. Criteri di esclusione: indicazione immediata a sostituzione valvolare aortica chirurgica o transcatetere, shock cardiogeno o edema polmonare refrattario a terapia medica. Risultati Sono stati arruolati 51 pazienti nel gruppo BAV con PR, 49 in quello senza PR (no-PR). Il successo procedurale (riduzione del 50% del gradiente medio emodinamico) è stato raggiunto in 37.3% e 55.1% dei casi rispettivamente (p=0.16). Meno pazienti nel gruppo no-PR hanno riferito scarsa tolleranza procedurale (16% vs 41%). L'endpoint primario di efficacia, una riduzione del 50% del gradiente medio transaortico all'eco-Doppler, è stato raggiunto in 21/49 pazienti nel gruppo no-PR rispetto a 20/51 in quello PR (42.9% vs 39.2%; p=0.84). Non si è osservata una differenza significativa nell'endpoint primario di sicurezza, dato dalla somma di morte a 30 giorni, infarto miocardico, stroke, insufficienza valvolare aortica acuta, e sanguinamenti BARC ≥3 (8.2% no-PR vs 13.7%; p=0.53). Il gruppo no-PR ha richiesto meno di frequente l'uso bailout del pacemaker temporaneo (p=0.048) ed ha visto un trend di minore incidenza di peggioramento lieve della funzione renale (4.1% vs 17.6%; p=0.052). Il calcolo del campione di popolazione per un ampio studio randomizzato, in relazione ad un outcome composito al netto degli eventi positivi/negativi occorsi nei due bracci di questo studio pilota, ha portato a considerare il futuro arruolamento di 343 pazienti in ciascun gruppo. Conclusioni La stimolazione ventricolare rapida non ha influenzato efficacia e sicurezza della BAV, comportando un lieve peggioramento della tolleranza alle procedure.Objective To compare the effectiveness and safety of balloon aortic valvuloplasty (BAV) performed with or without rapid ventricular pacing (RP). Background BAV technique is poorly standardized. Methods One hundred consecutive patients were randomly assigned 1:1 between BAV performed with or without RP. Exclusion criteria were an immediate indication for surgical or transcatheter aortic valve replacement, presentation in cardiogenic shock or pulmonary edema refractory to medical stabilization. Results There were fifty-one patients in the BAV group performed with RP, forty-nine in the BAV group without RP (no-RP). Procedural success (50% hemodynamic gradient reduction) was achieved in 37.3% and 55.1% respectively (p=0.16). Fewer people in the no-RP group complained of poor tolerance to the procedure (16% vs 41%). The primary efficacy endpoint, a 50% reduction in the mean echocardiographic trans-aortic gradient, was met in 21/49 patients in the no-RP group compared to 20/51 in the RP (42.9% vs 39.2%; p=0.84). No significant difference between the groups was observed in the primary safety endpoint, a 30-day composite of death, myocardial infarction, stroke, acute aortic regurgitation, and BARC bleeding ≥3 (8.2% no-RP vs 13.7%; p=0.53). The no-RP group required fewer bailout temporary pacemakers (p=0.048) and had a lower incidence of mild renal function worsening (4.1% vs 17.6%; p=0.052). The calculation of the population sample for a large randomized study, in relation to a composite outcome of the net rate of positive/negative events occurred in the two arms of this pilot study, led to consider the future enrollment of 343 patients in each group. Conclusions Rapid ventricular pacing did not influence BAV efficacy or safety and tolerance was slightly worse

Ruolo attuale dell'utilizzo di tirofiban come inibitore del recettore piastrinico glicoproteico IIb/IIIa

Ruolo attuale dell'utilizzo di tirofiban come inibitore del recettore piastrinico glicoproteico IIb/III

[The HEAT-PPCI study]

Background. La bivalirudina, in associazione con l\u2019uso selettivo degli inibitori della glicoproteina (GP) IIb/IIIa, rappresenta uno standard di cura riconosciuto nell\u2019angioplastica coronarica primaria (PPCI). Scopo dello studio \ue8 stato quello di confrontare la terapia antitrombotica con bivalirudina o eparina non frazionata nel corso di tale procedura. Metodi e risultati. Tra il 7 febbraio 2012 e il 20 novembre 2013, sono stati randomizzati 1829 pazienti su un totale di 1917 pazienti sottoposti ad angiografia d\u2019emergenza presso il nostro centro (pari al 97% dei pazienti afferiti consecutivamente), di cui 1812 inclusi nell\u2019analisi finale. 751 pazienti (83%) dei 905 inclusi nel gruppo bivalirudina e 740 pazienti (82%) dei 907 inclusi nel gruppo eparina sono stati sottoposti ad angioplastica coronarica. Il tasso di utilizzo degli inibitori della GP IIb/IIIa era sostanzialmente simile nei due gruppi (122 pazienti [13%] nel gruppo bivalirudina e 140 pazienti [15%] nel gruppo eparina). L\u2019endpoint primario di efficacia si \ue8 verificato in 79/905 pazienti (8.7%) del gruppo bivalirudina e in 52/907 pazienti (5.7%) del gruppo eparina (differenza di rischio assoluto 3.0%; rischio relativo [RR] 1.52, IC 95% 1.09-2.13, p=0.01). L\u2019\uadendpoint\uad primario di sicurezza si \ue8 verificato in 32/905 pazienti (3.5%) del gruppo bivalirudina e in 28/907 pazienti (3.1%) del gruppo eparina (differenza di rischio assoluto 0.4%; RR 1.15, IC 95% 0.70-1.89, p=0.59). Conclusioni. Rispetto alla bivalirudina, l\u2019eparina riduce l\u2019incidenza degli eventi ischemici avversi maggiori nel contesto della PPCI, a fronte di nessun incremento delle complicanze emorragiche. L\u2019uso sistematico di eparina, invece che di bivalirudina, si tradurrebbe in una sostanziale riduzione dei costi correlati al farmaco. [Lancet 2014;384:1849-58

Chronic total occlusion successfully treated with a bioresorbable everolimus-eluting vascular scaffold

Fully bioresorbable vascular scaffolds (BVS) are a new approach to the percutaneous treatment of coronary artery disease. The BVS have not yet been fully tested in complex lesions, including chronic total occlusion (CTO). We report a CTO case successfully treated with a second-generation bioabsorbable drug-eluting scaffold

Effective and equivalent organ doses in patients undergoing coronary angiography and percutaneous coronary interventions

Purpose: Recent recommendations of the International Commission on Radiological Protection state that the use of effective dose (E) for assessing patient exposure has severe limitations, though it can be kept for dose comparisons. In cardiology procedures, the equivalent dose (HT) is one of the most appropriate dose quantity to be evaluated for risk-benefit assessment. In this study, both E and HTvalues for ten critical organs in coronary angiography (CA) and percutaneous coronary interventions (PCI) were derived from in-the-field dose-area-product (DAP) measurements in order to provide a database for doses in those procedures. Methods: Conversion factors E/DAP calculated by Monte Carlo methods in two different mathematical human phantoms were applied to DAP values measured on 193 patients (118 CA and 75 PCI). Partial DAP values were recorded in-the-field for each projection and for all patients. The partial effective doses of all projections were summed up to calculate the E of the entire procedure. Similarly, equivalent doses for ten critical organs/tissues (bone, colon, heart, liver, lung, esophagus, red bone marrow, skin, stomach, and thyroid) were derived from HT/DAP conversion factors for different projections calculated by Monte Carlo method. Results: All parameters related to the patient dose, i.e., fluoroscopy times, number of images, DAP, effective doses, and equivalent doses, show a wide range of values depending on the complexity of the patient case and the experience of the cardiologist. The mean fluoroscopy time, DAP, and E values for coronary angiography patients were approximately threefold lower than those for PCI patients; the number of images for CA was half that for PCI. The correlation between effective dose and DAP was excellent for both CA and PCI. The equivalent doses values were in good correlations with DAP values in CA examinations, with Pearson's coefficients ranging from 0.87 (stomach) to 0.99 (skin) and rmean=0.94. The same analysis was performed for PCI procedures. In this case, the trends were only slightly worse because " r " ranged from 0.70 (stomach) to 0.92 (bone) and rmean=0.85. Simple conversion coefficients to estimate equivalent doses to ten critical organs/tissues from DAP values, for both CA and PCI, were provided for avoiding the need to carry out detailed in-the-field analysis for all projections and for all patients. Conclusions: Measurements in-the-field of DAP values were carried out for two common cardiology procedures and effective doses were derived for each technique from detailed analysis of dose and projection data, using conversion factors provided by two different theoretical models. Equivalent doses to organs/tissues were also calculated using conversion factors proposed in the literature for different projections and cumulative conversion factors HT/DAP for ten organs/tissues were estimated. \uc2\ua9 2011 American Association of Physicists in Medicine

Il ruolo degli stent riassorbibili e della tomografia a coerenza ottica nel trattamento della restenosi intrastent ricorrente: Un caso clinico

Il trattamento della restenosi intrastent recidivante rappresenta una sfida per il cardiologo interventista1. L\u2019imaging intracoronarico con tomografia a coerenza ottica (OCT) permette di caratterizzare la restenosi intrastent e pu\uf2 guidare la scelta terapeutica2

In the era of the valve-in-valve: is transcatheter aortic valve implantation (TAVI) in sutureless valves feasible?

Sutureless aortic valve implantation has emerged as an innovative alternative for treatment of aortic stenosis. By avoiding the placement of sutures, this approach aims to improve surgical outcomes by facilitating less traumatic minimally invasive approaches and reducing cross-clamp and cardiopulmonary bypass duration. However, the absence of sutures may have detrimental effects after sutureless interventions, including paravalvular leakages, valve dislocation, and stent-infolding. Transcatheter aortic valve-in-valve implantation (A-ViV) is emerging as a valuable procedure in patients with dysfunctioning biological aortic valves who are deemed inoperable with conventional surgery. Here we present the first-in-man case of trans-femoral implant of a balloon expandable aortic valve in a leaking sutureless self-expandable valve

Incidence, treatment, and outcome of acute aortic valve regurgitation complicating percutaneous balloon aortic valvuloplasty

Objectives: To evaluate the incidence, treatment, and outcomes of acute aortic regurgitation (ARR) complicating BAV. Background: In the transcatheter aortic valve implantation (TAVI) era, there is an increase of percutaneous balloon aortic valvuloplasty (BAV) procedures with different indications. Methods: From the prospective BAV registry of the University of Bologna, which has enrolled patients between the year 2000 and the present, we selected those who suffered intraprocedural AAR with overt hemodynamic instability. Worsening of baseline aortic insufficiency without hemodynamic collapse, treatment of degenerated biological valve prosthesis, and BAV performed within a planned TAVI procedure were excluded. The main endpoints were in-hospital and 30-day mortality. Results: Out of 1517 BAVs, we identified 26 cases of AAR (1.7%). This complication occurred in 80.8% of cases after one or two balloon inflations. Mean transaortic gradient decreased from 50.6\ua0\ub1\ua019.3 to 26.0\ua0\ub1\ua014.4 mm\ua0Hg (p\ua0<\ua00.01). In 8(30.8%) patients, AAR spontaneously resolved within few minutes; in 18 cases, the operators had to perform a rescue maneuver to reposition a valve leaflet got stuck in the opening position (this maneuver was successful in 13/18 of the cases, 72.2%). Out of 5 persistent AAR, 3 were managed with emergency TAVI or surgery, while 2 were unresolved. In-hospital mortality was 15.4% (n\ua0=\ua04), whereas no more deaths occurred up to 30 days. Conclusions: AAR is a fearsome complication of BAV and portends a grim prognosis. In some cases, it can be resolved with appropriate technical maneuvers; in others, a rescue TAVI or surgical valve replacement may be necessary. \ua9 2015 Wiley Periodicals, Inc