Clinical outcome after percutaneous coronary intervention with drug-eluting stent in bifurcation and nonbifurcation lesions: a meta-analysis of 23 981 patients.

BACKGROUND: PCI in CBL is common and technically demanding. Whether such patients have adverse outcome during the follow-up after successful PCI is unclear. We aim to compare the clinical outcome after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation of coronary bifurcation lesions (CBL) and non-CBL. METHODS: We performed a systematic literature search to identify studies reporting the clinical outcome of patients undergoing PCI in CBL or not. Patients with left main disease constituted a predefined subgroup. Primary study end-point was major adverse cardiac events (MACE). RESULTS: Fifteen publications on 23 891 patients with coronary artery disease treated by DES in CBL or not were identified. Median follow-up length was 24 months (range: 12-60). MACE at the longest available follow-up were significantly higher in CBL as compared with non-CBL (19.0 vs. 12.1%, P < 0.001). Similar results were obtained in the subanalysis restricted to second-generation DES studies. The MACE rate was higher early, then decreased during the follow-up being, however, appreciable at all timings up to 36 months. In the left main (LM) subanalysis (four studies, 3210 patients), patients underwent DES implantation in distal LM, as compared with nondistal LM, had increased the MACE rate during the follow-up (27.4 vs. 17.4%, P < 0.001), which was driven by higher target vessel revascularization. CONCLUSIONS: In the contemporary DES era, CBL represent a subset of lesions associated with increased rate of MACE after PCI. This data prompt for studies aimed at improving the clinical outcomes of patients with CAD.

A less-invasive totally-endovascular (LITE) technique for trans-femoral transcatheter aortic valve replacement.

OBJECTIVES: To describe and report the results of an original technique for trans-femoral (TF) transcatheter-aortic-valve-replacement (TAVR). BACKGROUND: TF approach represents the commonest TAVR technique. The best technique for TF-TAVR is not recognized. METHODS: We developed a less-invasive totally-endovascular (LITE) technique for TF-TAVR. The key aspects are: precise TAVR access puncture using angiographic-guidewire-ultrasound guidance radial approach as the "secondary access" (to guide valve positioning, to check femoral-access hemostasis and to manage eventual access-site complications) non-invasive pacing (by retrograde left ventricle stimulation or by definitive pace-maker external programmer) The LITE technique has been systematically adopted at our Institution. Procedure details, complications and clinical events occurring during hospitalization were prospectively recorded. Major vascular complications and life-threatening or major bleedings were the primary study end-points. RESULTS: A total of 153 consecutive patients referred for TF-TAVR were approached using the LITE technique. Mean predicted surgical operative mortality was 4.9% and mean TAVR predicted mortality was 3.9%. In 132 (86.3%) patients, TAVR was completed without the need for additional femoral artery access or transvenous temporary pace-maker implantation. Major vascular complications occurred in 2 (1.3%), life-threatening or major bleedings occurred in 4 (2.6%) patients. All-cause death occurred in 3 patients (2.0%). CONCLUSIONS: TF-TAVR according to LITE technique is feasible and is associated with very low rates of vascular or bleeding complications.

Usefulness of sheathless guiding catheters in patients with upper extremity vascular anomalies: Sheathless catheters in upper vascular anomalies.

AIMS: The transradial approach (TRA) reduces hospitalisation and access-site complications as compared to the transfemoral approach. Nevertheless, the TRA technical failure rate is significantly higher compared to the transfemoral approach. The high failure rate of TRA is due to a series of factors. In particular, a wide range of anatomic vascular variants hindering procedural success may be present in patients undergoing TRA procedures. METHODS AND RESULTS: In our retrospective observational study, 1,596 consecutive patients with upper limb vascular anomalies underwent TRA between January 2006 and July 2017. We evaluate the usefulness of the sheathless guiding catheter system (SG) as compared to the conventional guiding catheter (CG). The primary study endpoint was the "procedural success" defined as successful transradial procedure (both selective cannulation of the coronary ostium in the diagnostic procedure and successful stent delivery in the interventional procedure) without access change. All SG procedures were successful, whereas only 1,274 (86%) CG procedures were successfully performed (p=0.0001). At multivariable analysis, age (p=0.001) and sheathless catheter use (p=0.001) were independent predictors of procedural success. CONCLUSIONS: The sheathless GC is a safe and useful system not only for small radial access but also in the presence of upper vascular anomalies and it can be used in PCI and diagnostic procedures.

Long-Term Outcomes of Extent of Revascularization in Complex High Risk and Indicated Patients Undergoing Impella-Protected Percutaneous Coronary Intervention: Report from the Roma-Verona Registry.

OBJECTIVE: To investigate the effect of extent of revascularization in complex high-risk indicated patients (CHIP) undergoing Impella-protected percutaneous coronary intervention (PCI). BACKGROUND: Complete revascularization has been shown to be associated with improved outcomes. However, the impact of more complete revascularization during Impella-protected PCI in CHIP has not been reported. METHODS: A total of 86 CHIP undergoing elective PCI with Impella 2.5 or Impella CP between April 2007 and December 2016 from 2 high volume Italian centers were included. Baseline, procedural, and clinical outcomes data were collected retrospectively. Completeness of coronary revascularization was assessed using the British Cardiovascular Intervention Society myocardial jeopardy score (BCIS-JS) derived revascularization index (RI). The primary end-point was all-cause mortality. A multivariate regression model was used to identify independent predictors of mortality. RESULTS: All patients had multivessel disease and were considered unsuitable for surgery. At baseline, 44% had left main disease, 78% had LVEF ≤ 35%, and mean BCIS-JS score was 10±2. The mean BCIS-JS derived RI was 0.7±0.2 and procedural complications were uncommon. At 14-month follow-up, all-cause mortality was 10.5%. At follow-up, 67.4% of CHIP had LVEF ≥ 35% compared to 22.1% before Impella protected-PCI. Higher BCIS-JS RI was significantly associated with LVEF improvement (p=0.002). BCIS-JS RI of ≤ 0.8 (HR 0.11, 95% CI 0.01- 0.92, and p = 0.042) was an independent predictor of mortality. CONCLUSIONS: These results support the practice of percutaneous Impella use for protected PCI in CHIP. A more complete revascularization was associated with significant LVEF improvement and survival.

Novel ultra-long (48 mm) everolimus-eluting stent for diffusely coronary vessels disease.

BACKGROUND: Long drug-eluting stents may limit the need of stent overlaps in patients with diffusely diseased coronary arteries. We evaluated the clinical results of percutaneous-coronary-intervention (PCI) using a novel ultra-long (48 mm) everolimus-eluting stent (EES) in a real-word population. METHODS: Patients who underwent PCI with 48 mm EES between June 2015 and April 2017 in our Center were enrolled. The only exclusion criteria was cardiogenic shock established before PCI. Target vessels were divided in "very long lesion" (>38 mm) and "multiple focal disease" (multiple stenoses separated by healthy coronary segments >10 mm). Clinical follow-up was obtained to evaluate the occurrence of device-oriented composite endpoint (DOCE) (primary end-point). RESULTS: A total of 216 patients were identified (70.6±11 years, 48.1% acute coronary syndrome) who were treated on 230 vessels. The target vessel appearance was "very long lesion" in 44.8% of cases and "multiple focal disease" in 55.2%. A single 48-mm EES was implanted in 129 (56.1%), while additional overlapping stents were needed in 101 cases (43.9%). Total stent length was 64.9±24.0 mm. The median follow-up time was of 474 (411-614) days, DOCE occurred in 7% of patients. No stent thrombosis was noticed. At multivariate analysis, diabetes was associated with DOCE increase (P=0.02), while "multiple focal disease" predicted lower DOCE (P=0.02). CONCLUSIONS: The present real-world experience shows promising clinical results with the use of ultra-long stents in order to limit the need of stents overlaps in patients with diffuse coronary disease undergoing PCI.

Hemodynamics and its predictors during Impella-protected PCI in high risk patients with reduced ejection fraction.

BACKGROUND: Percutaneous ventricular-assistance by Impella (IMP) represents an emerging strategy to manage patients with reduced left-ventricular (LV) ejection-fraction (EF) undergoing percutaneous-coronary-intervention (PCI). The hemodynamic behave during IMP-protected PCI has been scarcely investigated. METHODS: We reviewed the IMP console's function and hemodynamic data (which are continuously recorded during assistance) in a consecutive series of 37 patients who underwent elective IMP-protected PCI in two high-volume centers. All patients had multivessel disease and impaired LVEF. Coronary artery disease burden was graded using the British-Cardiovascular-Intervention-Society jeopardy-score (BCIS-JS) score. IMP motor speed and pressure signals (systolic blood pressure, SBP, and mean blood pressure, MBP) were analyzed. Primary hemodynamic end-points were "critical systolic blood pressure (SBP) drop" (SBP decrease ≥ 20 mm Hg reaching ≤90 mm Hg values) and "critical mean blood pressure (MBP) drop" (MBP decrease reaching ≤60 mm Hg). RESULTS: Over mean assistance duration of 254 ±â€¯549 min, no IMP motor drop occurred. During PCI, SBP and MBP significantly decreased but all patients had SBP values >78 mm Hg. Critical SBP and MBP drops occurred in 10.8% of patients. Among all baseline and procedural characteristics, BCIS-JS was the only significant predictor of SBP drop (p = 0.001) while BCIS-JS and LV end-diastolic volume significantly predicted MBP drop (p = 0.001 for both). CONCLUSIONS: In patients with reduced EF undergoing IMP-protected PCI, a significant pressure decrease occurs during PCI but pressure is systematically maintained at levels warranting vital organ perfusion. Critical pressure drops during PCI occur in some patients with higher jeopardized myocardium and left ventricular diastolic volumes.

De novo cancer in patients on dialysis and after renal transplantation: north-western Italy, 1997-2012.

BACKGROUND: Kidney transplant recipients (KTR) are known to have a higher risk of cancer than the general population, especially of malignancies related to oncogenic viral infections. This study assessed the incidence of de novo malignancies (DNMs) in patients receiving kidney transplantation and in dialysis patients (DP) on the waiting list for transplantation at the same centre. The aim was to quantify the contribution of post-transplant immunosuppression to the underlying risk of developing a DNM in dialysis patients on the waiting list for kidney transplant. METHODS: Cancer incidence rates were computed using the Kaplan-Meier product-limit method. The number of DNMs observed in both groups was compared to the expected incidence in the general Italian population through calculation of the standardized incidence ratios (SIR) and their 95% confidence intervals (CI). To identify risk factors, incidence rate ratios (IRR) and 95% CIs were computed using Poisson regression analysis. The comparison of incidence rates between the two cohorts was also performed using age standardized incidence rates (ASR) and their ratio (age standardized rate ratio, ASRR). RESULTS: In 4858 person-years (PYs) of observation, 75 out of 735 KTR were diagnosed with DNM: 57 solid neoplasms, 13 post-transplant lymphoproliferative disorders (PTLD), and 12 Kaposi sarcomas (KS). The overall incidence was 17.5 cases/103 PYs, resulting in a 2.1-fold increased risk. Twenty-four out of 912 DP, over a follow-up of 2400 PYs, were diagnosed with a solid neoplasm, but none had PTLD or KS. The use of induction therapy after transplant was associated with a significant increased risk of KS (IRR: 3.52; 95% CI 1.04-11.98, p < 0.05). ASRR for all cancers and for solid cancers only was 1.84- and 1.19-fold higher in KTR, respectively, than in the general population. The overall incidence in DP was 10.0 cases/103 PYs, with a 1.6 significantly increased cancer risk compared to the general population. CONCLUSION: Our study confirms the increased risk of cancer after transplantation and during dialysis, but showed that virus-related cancers only occur after post-transplant immunosuppression.

Infection with hepatitis viruses, FIB-4 index and risk of hepatocellular carcinoma in southern Italy: a population-based cohort study.

BACKGROUND: The incidence of hepatocellular carcinoma (HCC) and its association with hepatitis C (HCV) and hepatitis B virus (HBV) infections, FIB-4 index and liver enzymes was assessed in an area of the province of Naples covered by a population-based cancer registry. METHODS: We conducted a cohort investigation on 4492 individuals previously enrolled in a population-based seroprevalent survey on HCV and HBV infections. The diagnosis of HCC was assessed through a record linkage with the cancer registry. Hepatic metabolic activity was measured through serum alanine transaminase, aspartate aminotransferase, gamma-glutamyl-transferase, and platelet. The FIB-4 index was used as a marker of fibrosis. We computed HCC incidence rates (IR) for 100,000 (105) person-years of observation, and multivariable hazard ratios (HR) with 95 % confidence intervals (CI) to assess risk factors for HCC. RESULTS: Twenty two cases of HCC were diagnosed during follow-up (IR = 63.3 cases/105). Significantly increased HCC risks were documented in individuals with higher than normal liver enzymes and low platelet count; in the 239 HCV RNA-positives (HR = 61.8, 95 % CI:13.3-286); and in the 95 HBsAg-positives (HR = 75.0) -as compared to uninfected individuals. The highest FIB-4 score was associated with a 17.6-fold increased HCC risk. CONCLUSIONS: An elevated FIB-4 index turned out to be an important predictor of HCC occurrence. Although the standard method to assess hepatic fibrosis in chronic hepatitis remains the histologic staging of liver biopsy specimen, the assessment of FIB-4 in HCV RNA-positive individuals may help in identifying the highest HCC-risk individuals who need anti-HCV treatment most urgently.

Head and neck and esophageal cancers after liver transplant: results from a multicenter cohort study. Italy, 1997-2010.

This study quantified the risk of head and neck (HN) and esophageal cancers in 2770 Italian liver transplant (LT) recipients. A total of 186 post-transplant cancers were diagnosed-including 32 cases of HN cancers and nine cases of esophageal carcinoma. The 10-year cumulative risk for HN and esophageal carcinoma was 2.59%. Overall, HN cancers were nearly fivefold more frequent in LT recipients than expected (standardized incidence ratios - SIR=4.7, 95% CI: 3.2-6.6), while esophageal carcinoma was ninefold more frequent (SIR=9.1, 95% CI: 4.1-17.2). SIRs ranged from 11.8 in LT with alcoholic liver disease (ALD) to 1.8 for LT without ALD for HN cancers, and from 23.7 to 2.9, respectively, for esophageal carcinoma. Particularly elevated SIRs in LT with ALD were noted for carcinomas of tongue (23.0) or larynx (13.7). Our findings confirmed and quantified the large cancer excess risk in LT recipients with ALD. The risk magnitude and the prevalence of ALD herein documented stress the need of timely and specifically organized programs for the early diagnosis of cancer among LT recipients, particularly for high-risk recipients like those with ALD.

Epidemiology of de novo malignancies after solid-organ transplantation: immunosuppression, infection and other risk factors.

Organ transplantation is an increasingly used medical procedure for treating otherwise fatal end-stage organ diseases, and a large number of anti-rejection drugs have been developed to prolong long-term survival of both the individual and the transplanted organ. However, the prolonged use of immunosuppressive drugs is well known to increase the risk of opportunistic diseases, particularly infections and virus-related malignancies. Although transplant recipients experience a nearly twofold elevated risk for all types of de novo cancers, persistent infections with oncogenic viruses are associated with up to hundredfold increased risks. Women of the reproductive age are growing in number among the recipients of solid-organ transplants, but specific data on cancer outcomes are lacking. This article updates evidences linking iatrogenic immunosuppression, persistent infections with oncogenic viruses, other risk factors and post-transplant malignancies. Epidemiological aspects, tumourigenesis related to oncogenic viruses, clinical implications, as well as primary and secondary prevention issues are discussed to offer clinicians and researchers alike an update of an increasingly important topic.