Luca Nai Fovino

Optimal duration of dual antiplatelet therapy after second-generation drug-eluting stent implantation in patients with diabetes: The SECURITY (Second-Generation Drug-Eluting Stent Implantation Followed By Six- Versus Twelve-Month Dual Antiplatelet Therapy)-diabetes substudy

BACKGROUND/OBJECTIVESnThe randomized SECURITY (Second-Generation Drug-Eluting Stent Implantation Followed by Six- Versus Twelve-Month Dual Antiplatelet Therapy) trial showed the non-inferiority of 6 vs. 12-month DAPT after percutaneous coronary intervention (PCI) with second-generation DES in a low-risk population. Nevertheless, diabetes mellitus (DM) remained a major predictor of adverse cardiovascular events. We aimed to assess the interaction between DAPT duration and outcome in DM patients.nnnMETHODSnAll diabetic patients included in the SECURITY trial treated by second-generation DES PCI were analyzed. The primary endpoint was a composite of cardiac death, myocardial infarction (MI), stroke, definite or probable stent thrombosis (ST), or Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 12months. The main secondary endpoint was a composite of cardiac death, MI, stroke, definite or probable ST, or BARC type 2, 3, or 5 bleeding at 24months.nnnRESULTSnFour hundred-twenty nine DM patients received either 6 (n=206) or 12 (n=223) months of DAPT. The primary endpoint occurred in 3.9% and 5.4% of patients in the 6 and 12-month DAPT group, respectively (log-rank test p=0.83). Similarly, no statistically significant difference in the secondary endpoint was observed between the two study groups (5.4% vs. 7.6%, p=0.620). Stent thrombosis rate was low irrespective of DAPT duration at both 12 (0.5% vs. 0.4%; p=0.804) and between 12 and 24months of follow-up (0.5% vs. 0%, p=0.291). At multivariable analysis, female gender (HR: 3.42; 95% CI 1.32-8.85; p=0.011 and HR 2.28; 95% CI 1.09-4.75; p=0.027) and insulin-treated diabetes mellitus (HR: 2.62; 95% CI 1.15-6.75; p=0.004 and HR: 2.23; 95% CI 1.09-6.33; p=0.003) were independent predictors of both primary and secondary endpoint.nnnCONCLUSIONSnIn diabetic patients treated by second-generation DES PCI, we failed to find any additional benefit of prolonging DAPT beyond 6months, regardless of insulin-requiring status.

Diagnostic and prognostic value of gated myocardial perfusion single-photon emission computed tomography in low-risk patients with left bundle-branch block

BackgroundThe abnormal left ventricular activation pattern in patients with a left bundle-branch block (LBBB) frequently induces myocardial perfusion defects, decreasing the specificity of noninvasive coronary-risk stratification with stress testing. We assessed the diagnostic and prognostic impact of gated single-photon emission computed tomography (SPECT) in low-risk patients with LBBB. MethodsA total of 114 patients underwent dual-day protocol Tc-99m sestamibi gated SPECT and were divided into two subsets: without LBBB (group 1, n=57) and with LBBB (group 2, n=57). Sixty-eight (60%) patients had negative coronary angiography and 46 (40%) were at a low risk for coronary artery disease. The variables incorporating the extent and severity of perfusion defects were calculated: summed stress score, summed rest score and summed difference score, end-diastolic volume (EDV), end-systolic volume (ESV), and left ventricular ejection fraction. The mean variations in EDV and ESV were computed as follows: rest volume−poststress volume. Cardiac events were classified as major and minor. ResultsGated SPECT was positive in eight (14%) patients of group 1 and 33 (58%) patients of group 2 (P<0.001). The summed stress score was significantly higher in group 2 than in group 1 (4.7±4.8 vs. 0.9±1.8, P<0.001); similarly, EDV and ESV were significantly higher in LBBB patients (P<0.05 in both). The mean variation in EDV was −2.21 ml for group 1 and 1.32 ml for group 2 (P<0.05). After a mean follow-up period of 32±19 months, cardiac events occurred in 22 (23%) patients, six of group 1 and 16 of group 2 (12 vs. 35%, P<0.01). ConclusionFunctional and perfusion parameters obtained by gated SPECT are different between patients with and without LBBB. In LBBB patients, the decrease in EDV between rest and poststress could be considered an early marker of diastolic dysfunction that might anticipate left ventricular ejection fraction reduction and may have an impact on prognosis.

Risk stratification and prognostic assessment by myocardial perfusion-gated SPECT in patients with left bundle-branch block and low-intermediate cardiac risk

ObjectiveIn high-risk patients with left bundle-branch block (LBBB), functional but not perfusion parameters yield incremental prognostic information. The aim of our study was to evaluate the prognostic value of gated single photon emission computed tomography (SPECT) in low-intermediate risk LBBB patients.MethodsOne hundred seventy-six subjects underwent stress-rest dual-day protocol 99mTc sestamibi-gated SPECT and were dichotomized in two groups: without LBBB (Group 1, nxa0=xa086) and with LBBB (Group 2, nxa0=xa090). Patients were followed for 32xa0±xa018xa0months. Cox regression multivariate analysis was used to determine which variable was the best predictor of cardiac event. Event-free survival curves were computed by Kaplan–Meier method.ResultsMyocardial perfusion scintigraphy was abnormal in 32 and 60 patients for Groups 1 and 2, respectively (37 vs. 67xa0%, pxa0<xa00.001). In Groups 1 and 2, the mean summed stress score (SSS) was 3.7xa0±xa05.6 versus 6.7xa0±xa06.4, while the mean summed difference score (SDS) was 1.6xa0±xa02.5 versus 2.7xa0±xa03.3 (both pxa0<xa00.005); therefore 34xa0% of patients in Group 1 and 53xa0% of those in Group 2 presented myocardial ischemia. All functional parameters were significantly different between the two subsets (all pxa0<xa00.005). Follow-up was completed in 161 patients (92xa0%); 10 events occurred in Group 1 and 20 in Group 2 (14 vs. 25xa0%). The event-free survival was significantly higher in patients with normal than in those with abnormal scan (85 vs. 63xa0%, pxa0<xa00.005); moreover, the prognosis of patients with LBBB was significantly worse. At multivariate analysis, SDS was found to be the only independent predictor of cardiac events both in all patients and in LBBB population (HR 3.08, and HR 4.99, pxa0<xa00.05).ConclusionsThis is the first study to assess the prognostic value of gated SPECT in patients with LBBB and low-intermediate cardiac risk. Both perfusion and functional data obtained by gated SPECT are different between patients with and without LBBB. However, SDS is the only predictor of events. Thus, the amount of reversible ischemia at gated SPECT has a discriminative power in stratifying the cardiac risk of LBBB population.

Prognostic value of myocardial perfusion scintigraphy in elderly patients with hypertension: a 10-year follow-up analysis

PurposeThe aim of the study was to assess the role of myocardial perfusion scintigraphy (MPS) in the prediction of future cardiac events in elderly hypertensive patients and to investigate if its prognostic value is maintained during a 10-year follow-up period.MethodsA total of 229 consecutive patients ≥ 65 years old (range 65–88 years) with arterial hypertension, who were referred to our institution for stress/rest 99mTc-sestamibi MPS between January 2000 and November 2001, were followed up for 10–12 years. Cardiac death, myocardial infarction and a coronary revascularization procedure were considered as events. Survival curves were computed by the Kaplan-Meier method. A stepwise Cox proportional hazards analysis was used to identify predictors of events.ResultsFollow-up was completed in 221 (96.5xa0%) patients; 26 patients experienced cardiac death, 29 myocardial infarction and 51 coronary revascularization. Annual event rates for cardiac death, cardiac death/myocardial infarction and cardiac death/myocardial infarction/coronary revascularization were, respectively, 0, 0.2 and 0.4xa0% for patients with a normal scan and 1.5, 3.0 and 5.3xa0% after an abnormal MPS. Event-free survival was significantly different according to extent and severity of perfusion defects (all pu2009<u20090.01). An increase in global chi-square in predicting cardiac events occurred when MPS data were added to pre-scan information (from 47.28 to 88.87; pu2009<u20090.001).ConclusionMPS provides incremental prognostic information for the prediction of cardiac events in elderly patients with hypertension. Subjects with a normal scan have an excellent 10-year outcome, and the risk of experiencing a cardiac event increases with extension and severity of stress perfusion defect.

Transcatheter aortic valve implantation in lower-risk patients: what is the perspective?

In the last decade, transcatheter aortic valve implantation (TAVI), a disruptive technology, has revolutionized the therapy of symptomatic severe aortic stenosis, and current guidelines state that the recommendations for TAVI and surgical aortic valve replacement (SAVR) are equivalent in patients at high-risk. Increased operator experience, technical advances in the new generation of transcatheter heart valves (THV) and excellent TAVI results in recently published randomized controlled trials have led to the expansion of TAVI indication as an alternative to SAVR in intermediate-risk subjects, given appropriate patient selection. The time is opportune to examine the role of TAVI in low-risk patients, currently the objective of on-going randomized trials. This review aims to summarize the available knowledge on TAVI in low- to intermediate-risk patients and to discuss the potential advantages and pitfalls TAVI will face in this clinical setting.

Left ventricular outflow tract rupture during transcatheter aortic valve implantation: Anatomic evidence of the vulnerable area

• The case reported, together with a review of the literature of all published cases, illustrates the value of clinic–pathologic correlation to assess the anatomic basis of complication during interventional procedures.

“Full-plastic jacket” with everolimus-eluting Absorb bioresorbable vascular scaffolds: Clinical outcomes in the multicenter prospective RAI registry (ClinicalTrials.gov Identifier: NCT02298413)

OBJECTIVESnThe objective of this study was to investigate mid-term clinical outcomes of patients treated with full-plastic jacket (FPJ) everolimus-eluting Absorb bioresorbable vascular scaffold (BRS) implantation.nnnBACKGROUNDnFPJ with BRS may represent an interesting option for patient with diffuse coronary artery disease (CAD), but data on the clinical impact of FPJ using the Absorb BRS are scant.nnnMETHODSnFPJ was defined as the implantation of >56u202fmm of overlapping BRS in at least one vessel. We compared outcomes of patients receiving Absorb FPJ vs. non-FPJ within the multicenter prospective RAI Registry.nnnRESULTSnOut of 1505 consecutive patients enrolled in the RAI registry, 1384 were eligible for this analysis. Of these, 143 (10.3%) were treated with BRS FPJ. At a median follow-up of 649u202fdays, no differences were observed between FPJ and non-FPJ groups in terms of the device-oriented composite endpoint (DoCE) (5.6% vs. 4.4%, pu202f=u202f0.675) or the patient-related composite endpoint (PoCE) (20.9% vs. 15.9%, pu202f=u202f0.149). Patients receiving FPJ had higher rates of target vessel repeat revascularization (TVR) (11.2% vs. 6.3%, pu202f=u202f0.042). In the FPJ group, there was no cardiac death and only one (very late) stent thrombosis (ST) (0.7%).nnnCONCLUSIONSnMid-term outcomes of a FPJ PCI strategy in the setting of diffuse CAD did not show a significant increase in composite device- and patient-related events, with rates of cardiac death and ST comparable to non-FPJ Absorb BRS implantation. However, these findings are hypothesis generating and requiring further validation.

Pulmonary artery rupture during right heart catheterization: successful endovascular treatment with Amplatzer Vascular Plug

An 84-year-old man with post-ischaemic dilated cardiomyopathy and moderate-to-severe functional mitral regurgitation complicated by pulmonary hypertension underwent right heart catheterization at our centre. During pulmonary capillary wedge pressure measurements with 7 Fr Swan-Ganz catheter (Edwards Lifesciences, Irvine, CA, USA), the patient developed massive haemoptysis and haemorrhagic shock, requiring endotracheal intubation and cardiopulmonary resuscitation. Selective contrast injection in the right pulmonary artery revealed a ruptured subsegmental branch actively bleeding into the airways (Panel A, Supplementary material online, Video S1).

The interplay between permanent pacemaker implantation and mortality in patients treated by transcatheter aortic valve implantation: A systematic review and meta-analysis

Previous implantation of a permanent pacemaker (PPM) is common among patients undergoing transcatheter aortic valve implantation (TAVI). Moreover, onset of conduction disturbances needing new PPM implantation after TAVI is frequent. The interplay of pre‐existing and new‐PPM on mortality after TAVI remains controversial.

Transcatheter versus surgical aortic valve replacement in low- and intermediate-risk patients: an updated systematic review and meta-analysis

Transcatheter aortic valve replacement (TAVR) has been recognized as a well-established alternative to surgical aortic valve replacement (SAVR) for symptomatic aortic stenosis with high surgical risk. With this updated systematic review and meta-analysis, we evaluated TAVR vs. SAVR in low- and intermediate-risk subjects. Studies comparing TAVR and SAVR in low-risk patients (defined as STSu2009≤u20098% or EuroSCOREu2009≤u200920%) were identified with electronic searches. The principal endpoint was all-cause mortality at short term (<u20093xa0months), 1, and 2xa0years. Other outcomes of interest were cardiac mortality, neurological events, paravalvular leakage (PVL), myocardial infarction (MI), major bleeding, acute kidney injury (AKI), vascular complications, and new pacemaker (PM) implantation. Seventeen articles including 9805 (4956 TAVR and 4849 SAVR) patients were eligible. There was no significant difference in all-cause mortality at short term [odds ratio (OR) 0.83, 95% confidence interval (CI) 0.63–1.09], 1xa0year (OR 1.01, 95% CI 0.86–1.20) and 2xa0years (OR 0.86, 95% CI 0.64–1.16) between treatment groups. Subgroup analyses stratified by surgical risk score (low-risk subgroup: STSu2009<u20094% or EuroSCOREu2009<u200910%, intermediate-risk subgroup: the others) did not show interaction on primary endpoints. Compared to SAVR, TAVR had similar rates of neurological events, significantly lower risk of MI and AKI, but higher risk of vascular complications, new PM implantation and moderate/severe PVL. In low- and intermediate-risk patients, TAVR and SAVR have similar short- and mid-term all-cause mortality. Compared to SAVR, TAVR carries higher rates of vascular complications, PM implantation and moderate/severe PVL, but lower risk of MI and AKI.