Drug‐coated balloons—the importance of packing and dosing antiproliferative drugs

• Several balloon catheters coated with paclitaxel have been shown to reduce restenosis rates in the superficial femoral artery (SFA) revealing a relatively wide therapeutic window of effective doses ranging from 2 to 3 µg/mm² balloon surface area
• Delivering lower antiproliferative drug doses to the vessel wall may not be inferior to higher drug doses provided that effective drug‐excipient formulations have been chosen
• Leaving non‐flow limiting dissection in the SFA non‐stented might be an option after use of drug‐coated balloons

     

Dynamics of liver stiffness by transient elastography in patients with chronic hepatitis C virus infection receiving direct‐acting antiviral therapy—Results from the German Hepatitis C‐Registry

The impact of direct‐acting antiviral (DAA) therapies on fibrosis regression remains uncertain. In the current study, we prospectively evaluated dynamics of liver stiffness by transient elastography (TE) in patients with chronic HCV infection receiving DAA‐based treatment. Patients (260) were enrolled in the German Hepatitis C‐Registry (DHC‐R), a national multicentre real‐world cohort. Liver stiffness (LS) was assessed at baseline, end of treatment (EOT) and 24 weeks after EOT (FU24) by TE. Biochemical, virological and clinical data were obtained in parallel. In patients with SVR, there was a significant improvement of LS between baseline (median [range], 8.6 [1.7‐73.5] kPa) and FU24 (7.9 [1.7‐75 kPa]; P < .0001) as well as between EOT (8.4 [1.7‐73.5 kPa]) and FU24 [P < .0001]. Stratified by fibrosis stage, patients classified into F4 had higher magnitude of LS reduction between BL (median [range], 25.1 [13.5‐73.5] kPa) and FU24 (21.5 [3.1‐75] kPa; P = .002) compared to those with F2‐F3 (8.9 [7.1‐12.4] kPa and 8.8 [4.2‐29.1]; P = .060) or F0‐F1 (5.3 [1.7‐7] kPa and 5.2 [1.7‐7.7]; P = .064). In cirrhotic patients, low platelets were significantly associated with lack of liver stiffness improvement, both at EOT (P = .018) and at FU24 (P = .012). LS significantly correlated with ALT (r = .371), AST (r = .552), platelets (r = ?.499), GGT (r = .250), bilirubin (r = .230), APRI score (r = .512), FIB‐4 score (r = .517) and FORNS index (r = .562); P < .0001. Liver elastography improved significantly in our real‐world cohort after DAA‐based therapy. As LS correlates similarly with transaminase levels and serum fibrosis markers, it might reflect both reduction of necroinflammation and fibrosis regression.     

Leptin—a predictor of abnormal glucose tolerance and prognosis in patients with myocardial infarction and without previously known Type 2 diabetes

Aims High levels of leptin and low adiponectin are associated with Type 2 diabetes mellitus (T2DM) and cardiovascular (CV) disease. We studied the prognostic implications of leptin and adiponectin in patients with acute myocardial infarction (AMI) without previously known Type 2 DM. Methods One hundred and eighty‐one patients were included. Based on an oral glucose tolerance test at hospital discharge (day 4–5), 168 (67% men) had normal or abnormal glucose tolerance (AGT), defined as impaired glucose tolerance or T2DM. Sex‐ and age‐matched healthy persons served as control subjects (n = 185). The associations between fasting serum leptin and adiponectin (day 2) and newly discovered AGT and CV events (CV mortality, non‐fatal stroke, reinfarction or severe heart failure) during a median follow‐up of 34 months were investigated. Results Compared with control subjects, patients of both genders had significantly higher levels of leptin 2 days after an AMI. These levels were higher than those obtained at hospital discharge and 3 months later. Circulating levels of (ln) leptin 2 days after the AMI predicted AGT at discharge (odds ratio 2.03, P = 0.042). Ln leptin at day 2 was the only biochemical variable that significantly predicted CV events both on univariate [hazard ratio (HR) 1.60, P = 0.018] and on multivariate analysis (HR 1.75, P = 0.045). Adiponectin levels did not differ between patients and control subjects and did not relate to AGT or CV events. Conclusions Elevated circulating levels of leptin on the first morning after an AMI are associated with the presence of AGT at discharge and with a poorer long‐term prognosis.     

Stenting in unprotected left main coronary stenosis—“What no progress”?

• There does not appear to be a difference in patient outcomes of percutaneous coronary intervention for unprotected left main coronary artery stenosis whether using first‐ or second‐generation drug elutting stent.
• This is despite increase in patients having more adjunctive procedures such as intravascular imaging and newer generation antiplatelet agents.
• This single‐center study provokes questions as to why there has not been improvement in outcomes.

     

BATMAN—Savior or vigilante?

• BATMAN is a new technique to prevent left ventricular outflow tract (LVOT) obstruction from transcatheter mitral valve replacement (TMVR) by deploying the transcatheter heart valve from the apex through a perforation of the anterior mitral valve leaflet.
• The risks of uncontrolled balloon dilatation of the anterior mitral valve leaflet include extension of the tear superiorly into the aorto‐mitral curtain or laterally to avulse the trigone from the annulus.
• Percutaneous laceration of the anterior mitral leaflet, pre‐emptive alcohol septal ablation, and transatrial leaflet resection are alternative strategies that prevent LVOT obstruction from TMVR

     

An Audit of Outcomes After Same‐Day Discharge Post‐PCI in Acute Coronary Syndrome and Elective Patients

Objectives

To investigate the outcomes of a cohort of acute and elective percutaneous coronary intervention (PCI) patients who were discharged home 6 hours postprocedure.

Background

Contemporary PCI is safe with a low rate of acute complications. It is well established as a day procedure in elective cases; however, data are lacking in acute cases.

Methods

We describe a prospective observational audit of routine clinical practice in the 3 PCI centers in Northern Ireland. Patients were selected for same‐day discharge after 6 hours of post‐PCI observation. Both elective and acute coronary syndrome (ACS) cases were included. Criteria for same‐day discharge were based on the technical result of the procedure rather than lesion complexity or clinical presentation. Radial access was preferred but not mandatory. Patients were contacted directly to assess for 30‐day major adverse cardiovascular events (MACE). Reported events were corroborated with the general practitioner or hospital notes.

Results

A total of 1,059 patients were selected for same‐day discharge with 30‐day follow‐up available for all cases. Of these, 766 (72.3%) were elective and 293 (27.7%) were ACS patients. Radial access was almost universal (98%). A total of 1,224 lesions were stented, of which 432 (40.8%) were high risk (highest risk lesion in each case by AHA/ACC classification). MACE rate at 30 days was 0.85% with a sub‐acute stent thrombosis rate of 0.4%. There were no MACE events from discharge to 24 hours.

Conclusions

Selected acute and elective patients with a range of lesion complexity and risk can be discharged safely home early after PCI.

     

Two‐Year Effects of Interdisciplinary Intervention for Hip Fracture in Older Taiwanese

OBJECTIVES: To explore the 2‐year outcomes of an interdisciplinary intervention for elderly patients with hip fracture. DESIGN: Randomized experimental design. SETTING: A 3,000‐bed medical center in northern Taiwan. PARTICIPANTS: Patients with hip fracture (N=162): 80 in the intervention group and 82 in the usual care control group. INTERVENTION: An interdisciplinary program of geriatric consultation, continuous rehabilitation, and discharge planning. MEASUREMENTS: Outcomes (clinical outcomes, self‐care ability, health‐related quality of life (HRQoL), service utilization, and depressive symptoms) were assessed 1, 3, 6, 12, 18, and 24 months after discharge. Self‐care ability (ability to perform activities of daily living (ADLs)) was measured using the Chinese Barthel Index. HRQoL was measured using the Medical Outcomes Study 36‐item Short Form Survey, Taiwan version (SF‐36). Depressive symptoms were measured using the Chinese Geriatric Depression Scale, short form. RESULTS: Subjects in the intervention group had significantly better ratios of hip flexion (β=5.43, P<.001), better performance on ADLs (β=9.22, P<.001), better recovery of walking ability (odds ratio (OR)=2.23, P<.001), fewer falls (OR=0.56, P=.03), fewer depressive symptoms (β=?1.31, P=.005), and better SF‐36 physical summary scores (β=6.08, P<.001) than the control group during the first 24 months after discharge. The intervention did not affect the peak force of the fractured limb's quadriceps, mortality, service utilization, or SF‐36 mental summary score. CONCLUSION: The interdisciplinary intervention for hip fracture benefited elderly persons with hip fracture by improving clinical outcomes, self‐care ability, and physical health–related outcomes and by decreasing depressive symptoms during the first 24 months after hospital discharge.     

What patients want

• Patients may have preferences and priorities for their catheterization procedure that may differ from the operator's expectations.
• This online survey of normal volunteers suggested that patients place the highest value on same‐day discharge and lesser values for radiation exposure, bleeding risk, and access site.
• Patient‐centered care needs to increasingly emphasize same‐day discharge after PCI for highest patient satisfaction.

     

Cardiac enzyme elevation after coronary revascularization

• CK‐MB elevation post‐PCI correlates with procedural complications, diffuse atherosclerosis, and adverse long‐term prognosis.
• Troponin elevation has an earlier pattern of rise than CK‐MB and can be used as a surrogate.
• High sensitivity troponin can enable ruling out enzymatic elevation very early after PCI and facilitate discharge timing.

     

A match not made in heaven—TAVR prosthesis‐patient mismatch with contemporary valves

• Prosthesis‐patient mismatch (PPM) in TAVR is relatively common
• Valve oversizing can potentially prevent both paravalvular leak and PPM
• PPM may be avoidable if the expected Effective Orifice Area/Body Surface Area ratio is considered in decision making pre‐TAVR.

     

Transcatheter versus surgical aortic valve replacement in the digital era: Meta‐analysis based on the reconstruction of time‐to‐event individual patient data

• Clinical benefits of transcatheter aortic valve replacement (TAVR) over surgery emerge soon after intervention and show durable, consistent trends within 1 year.
• TAVR by transfemoral access is associated with improved outcomes compared with TAVR by transthoracic access.
• Reconstructing time‐to‐event individual patient data is advantageous and allows higher flexibility in terms of meta‐analysis design and modeling of data.

     

Large device for large atrial septal defects—the 40 mm Atrial Septal Occluder

• The 40 mm ASO device can be used with a high rate of successful implantation for ASD closure
• The technique of implantation usually requires more than simple direct, device placement
• Balloon‐assisted technique (BAT) can make use of this large occluder more predictable
• Experience contributes significantly to procedure success
• Important complications, such as device embolization will occur in a small number of cases
• Thrombotic complications are infrequent, even with aspirin monotherapy

     

Deploying bioresorbable vascular scaffolds—tardus,altius, amplius!!

• Current generation bioresorbable vascular scaffolds (BVS) have thick struts and relatively low radial strength; meticulous deployment is required to prevent underexpansion while avoiding stent fracture.
• The current study suggests safety of very high‐pressure (mean 28 atm) post‐dilation of BVS with a noncompliant balloon.
• Duration of inflation and inflation pressure stabilization are important factors that influence the extent of optimal stent expansion and should be studied in future attempts to optimize BVS deployment.

     

Microvascular function in non‐dippers: Potential involvement of the salt sensitivity biomarker,marinobufagenin—The African‐PREDICT study

Suppressed nighttime blood pressure dipping is associated with salt sensitivity and may increase the hemodynamic load on the microvasculature. The mechanism remains unknown whereby salt sensitivity may increase the cardiovascular risk of non‐dippers. Marinobufagenin, a novel steroidal biomarker, is associated with salt sensitivity and other cardiovascular risk factors independent of blood pressure. The authors investigated whether microvascular function in non‐dippers is associated with marinobufagenin. The authors included 220 dippers and 154 non‐dippers (aged 20‐30 years) from the African‐PREDICT study, with complete 24‐hour urinary marinobufagenin and sodium data. The authors determined dipping status using 24‐hour blood pressure monitoring and defined nighttime non‐dipping <10%. The authors measured microvascular reactivity as retinal artery dilation in response to light flicker provocation. Young healthy non‐dippers and dippers presented with similar peak retinal artery dilation, urinary sodium, and MBG excretion (P > .05). However, only in non‐dippers did peak retinal artery dilation relate negatively to marinobufagenin excretion after single (r = ?0.20; P = .012), partial (r = ?0.23; P = .004), and multivariate‐adjusted regression analyses (Adj. R² = 0.34; β = ?0.26; P < .001). The authors also noted a relationship between peak artery dilation and estimated salt intake (Adj. R² = 0.30; β = ?0.14; P = .051), but it was lost upon inclusion of marinobufagenin (Adj. R² = 0.33; β = ?0.015; P = .86). No relationship between microvascular reactivity and marinobufagenin was evident in dippers (P = .77). Marinobufagenin, representing salt sensitivity, may be involved in early microvascular functional changes in young non‐dippers and thus contributes to the development of hypertension and cardiovascular disease later in life.     

Post‐TAVR aortogram: Transform it into a modern tool for prognosis and efficiency

• Video densitometry after aortography can provide objective assessment of aortic regurgitation post‐transcatheter aortic valve replacement (TAVR)
• Contrast density ratio between the left ventricular outflow track and proximal aorta (LVOT‐AR) of >0.17 suggests greater than mild aortic insufficiency and correlates with echo findings
• LVOT‐AR of >0.17 is associated with higher 30‐day and 1‐year mortality

     

Acute kidney injury after TAVI: Predict,detect, and prevent

• Acute kidney injury (AKI) is frequently observed immediately after transcatheter aortic valve implantation (TAVI).
• Both classifications, the RIFLE (the Risk, Injury, Failure, Loss, and End‐stage Kidney) and the KDIGO (Kidney Disease: Improving Global Outcomes) from the VARC‐2 (Valve Academic Research Consortium‐2) are fairly interchangeable and performed well as clinical predictors of all‐cause mortality.
• Patients with baseline reduced glomerular filtration rate (GFR) or known atherosclerotic arterial disease are at increased risk of AKI.

     

Guidelines on travel‐related venous thrombosis

• ? Long duration travel is a weak risk factor for the development of venous thromboembolism (VTE). The incidence of VTE after flights of >4 h is 1 in 4656 and for flights of more than 8 h in low and intermediate risk flyers is around 0·5%.
• ? Severe symptomatic pulmonary embolism in the period immediately after travel is extremely rare after flights of <8 h. In flights over 12 h the rate is 5 per million.
• ? VTE may be attributable to travel if it occurs up to 8 weeks following the journey.
• ? The risk of travel‐related thrombosis is higher in individuals with pre‐existing risk factors for the development of VTE.
• ? There is no evidence for an association between dehydration and travel‐associated VTE and so whilst maintaining good hydration is unlikely to be harmful it cannot be strongly recommended for prevention of thrombosis (recommendation grade 2, level of evidence, B).
• ? There is indirect evidence that maintaining mobility may prevent VTE and, in view of the likely pathogenesis of travel‐related VTE, maintaining mobility is a reasonable precaution for all travellers on journeys over 3 h (2B).
• ? Global use of compression stockings and anticoagulants for long distance travel is not indicated (1C).
• ? Assessment of risk should be made on an individual basis but it is likely that recent major surgery (within 1 month), active malignancy, previous unprovoked VTE, previous travel‐related VTE with no associated temporary risk factor or presence of more than one risk factor identifies those travellers at highest thrombosis risk (1C).
• ? Travellers at the highest risk of travel‐related thrombosis undertaking journeys of >3 h should wear well fitted below knee compression hosiery (2B).
• ? Where pharmacological prophylaxis is considered appropriate, anticoagulants as opposed to anti‐platelet drugs are recommended based on the observation that, in other clinical scenarios, they provide more effective thromboprophylaxis. Usual contraindications to any form of thromboprophylaxis need to be borne in mind (2C).

     

Feasibility of Early Discharge After Implantable Cardioverter‐Defibrillator Procedures

Early Discharge After ICD Implantation . Introduction: Registry data demonstrate considerably low complication rates after implantable cardioverter‐defibrillator (ICD) procedures for primary prevention of sudden death. Yet standard of care includes postimplant overnight in‐hospital observation that may levy substantial unnecessary financial burden on health care systems. In appropriate patients, discharge soon after implant could translate into significant cost savings, if such practice does not result in complications. We applied a simple clinical algorithm to assess feasibility of discharge on the same day of ICD implantation in patients at low risk for procedural complications. Methods: We prospectively randomized primary prevention ICD candidates at low risk for complications (not pacing‐dependent or requiring bridging heparin anticoagulation) to next‐day discharge with overnight in‐hospital observation, or same‐day discharge with remote monitoring for 24 hours after ICD implant. Implants were performed via cephalic vein access, and randomization occurred after 4‐hours clinical observation and device interrogation. All patients were followed for a minimum of 6 weeks to assess acute procedural complications. Results: 71 patients comprised the study cohort (mean age 62, 79% male) after 3 were excluded. The most common indication for ICD implant was ischemic cardiomyopathy with ejection fraction ≤35%. Device data obtained through 24‐hour remote monitoring was comparable to 4‐hour postimplant parameters in same‐day discharge patients. No acute complications occurred in same‐day discharge patients; 1 next‐day discharge patient developed pneumothorax. Conclusion: ICD implantation with same‐day discharge is reasonable in patients at low risk for complications. Remote monitoring can be useful in indicating lead‐parameter stability during the immediate postoperative period. (J Cardiovasc Electrophysiol, Vol. 23 pp. 1123‐1129, October 2012)     

Suprasternal access for transcatheter aortic valve implantation: All ways lead to Rome

• What the article teaches . Suprasternal (SS) access to the innominate artery is an easy and very safe approach for transcatheter aortic valve implantation (TAVI) when transfemoral (TF) access is not feasible.
• How it will impact practice . In experienced hands, SS TAVI could become the preferred alternative approach for non‐TF TAVI.
• What new research/study would help answer the question posed . The hypothesis of superior safety of SS access for TAVI in comparison with other non‐TF approaches should be investigated in dedicated studies.

     

Same or next day discharge: A new chapter in transcatheter aortic valve implantation

• As more patients become eligible for transcatheter aortic valve implantation (TAVI), resource allocation and early discharge planning require careful consideration.
• TAVI centers must develop locally appropriate and systematic strategies to facilitate early discharge and seamless post‐discharge care.
• While ongoing studies examine pacing requirements post‐TAVI, trials comparing general anesthesia and monitored analgesia care are desired. Future technologies for co‐registration of computed tomography with fluoroscopy may reduce the need for intra‐operative transesophageal echo and general anesthesia. A tailored patient-centered approach is essential to optimize in-hospital stay and overall patient experience.