Long-term outcomes following drug-eluting balloon or thin-strut drug-eluting stents for treatment of in-stent restenosis stratified by duration of dual antiplatelet therapy (DEB-Dragon Registry).

Introduction: Data regarding the duration of dual antiplatelet therapy (DAPT) in patients with drug-eluting stent restenosis (DES-ISR) treated with percutaneous coronary intervention (PCI) and drug-eluting balloons (DEB) or DES are not unambiguous. Aim: To evaluate the relationship between long-term outcomes and the length of DAPT in patients treated with PCI due to DES-ISR with DEB or DES. Material and methods: Overall, a total of 1,367 consecutive patients with DES-ISR, who underwent PCI with DEB or DES between 2008 and 2019 entered the study. The mean length of the follow-up was 1,298.7 ±794 days. We assessed study endpoints according to the duration of DAPT (≤ 3 vs. > 3 and ≤ 6 vs. > 6 months) before and after propensity score matching (PSM): stroke, target lesion revascularisation (TLR), target vessel revascularisation (TVR), myocardial infarction (MI), death and device oriented composite endpoints (DOCE). Kaplan-Meier estimates were created to differentiate long-term outcomes. Results: Pairwise contrast analysis considering type of PCI (DES vs. DEB) and duration of DAPT (≤ 6 vs. > 6 months) before PSM revealed superiority of DES + DAPT > 6 months vs. DEB + DAPT > 6 months for DOCE (p < 0.001), TVR (p = 0.02) and TLR (p = 0.01). Also, DES + DAPT ≤ 6 months was found to be superior compared to DEB + DAPT ≤ 6 months for DOCE (p < 0.001), TVR (p = 0.02) and TLR (p = 0.01). Kaplan-Meier estimate analysis confirmed that DAPT > 6 months is related to a higher stroke rate (p = 0.01) when compared to ≤ 6 months. Conclusions: Treatment with DAPT in patients with DES-ISR is related to better long-term outcomes in the case of PCI with DES than DEB. DAPT > 6 months is related to the greater rate of strokes, independently of the type of treatment (DES and DEB) than DAPT ≤ 6 months.

Long-term outcomes following drug-eluting balloons vs. thin-strut drug-eluting stents for treatment of recurrent restenosis in drug-eluting stents.

BACKGROUND: There is limited data on the optimal revascularization strategy in patients with recurrent in-stent restenosis (R-ISR). AIMS: To compare the long-term outcomes of patients treated with either a thin-strut drug-eluting stent (thin-DES) or a drug-eluting balloon (DEB) for R-ISR in a drug-eluting stent (DES). METHODS: A multicenter DEB-DRAGON registry was used to retrospectively identify patients with R-ISR who received either a thin-DES or a DEB. Propensity score matching was applied to adjust for baseline differences. The primary outcome was target lesion revascularization (TLR). RESULTS: Out of 311 patients (mean age, 67 years; 63% male) with R-ISR, 86 (27.7%) were treated with a thin-DES and 225 (72.3%) with a DEB. Median follow-up was 2.6 years. TLR occurred in 18 (20.9%) patients who received thin-DES and 61 (27.1%) patients treated with DEB (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.33-0.98; log-rank P = 0.04). The difference remained significant in a propensity score-matched cohort of 57 patients treated with thin-DES and 57 patients treated with a DEB (17.5 vs. 33.3%, respectively; HR, 0.38; 95% CI, 0.17-0.86; P = 0.01). The risks of device-oriented adverse cardiac events and all-cause mortality were similar after thin-DES or DEB in both unadjusted and propensity score-matched cohorts. In a multivariable Cox proportional hazard model, the treatment with a thin-DES was an independent predictor of a TLR-free survival (HR, 0.33; 95% CI 0.13-0.84; P = 0.02). CONCLUSIONS: In patients with R-ISR implantation of a thin-DES is associated with a lower risk of repeated revascularization compared with angioplasty with a DEB.

Long-Term Outcomes Following Drug-Eluting Balloons Versus Thin-Strut Drug-Eluting Stents for Treatment of In-Stent Restenosis (DEB-Dragon-Registry).

[Figure: see text].

Frailty and cognitive impairment are predictive of takotsubo syndrome following pacemaker implantation.

BACKGROUND: Pacemaker (PM) implantation may cause acute emotional distress leading to takotsubo syndrome (TTS). Frailty and cognitive impairment are known to influence outcomes after surgical procedures. It is unclear whether they may also predispose to TTS following PM implantation. METHODS: We identified nine cases (81 ± 6 years) of TTS following PM implantation that took place between 2013 and 2017 in one high volume implantation center. TTS was diagnosed based on typical echocardiographic appearance with resolution over time and (in cases where deemed necessary) normal coronary angiography. The TTS cases were compared with 30 consecutive cases of PM implantation (75 ± 9 years), which were not complicated by TTS (control group). Frailty was assessed using retrospective Risk Analysis Index (RAI-A). Pacing parameters were analyzed during PM implantation and after 1 month. RESULTS: Cognitive impairment was more prevalent (67% vs 10%, P = .0005), and RAI-A index was significantly higher in the TTS group compared to the control group (26 ± 13.7 vs 13.1 ± 9.8, P = .008). Perioperative right ventricular threshold was significantly higher in patients with TTS comparing to controls (0.99 ± 0.43 V vs 0.74 ± 0.20 V, P = .04). The magnitude of decrease in right ventricular threshold between implantation and 1 month follow-up was greater in TTS patients compared to controls (-0.41 ± 0.29 V vs -0.15 ± 0.38 V, P = .049). CONCLUSIONS: TTS is a rare complication of PM implantation. Patients with cognitive impairment and frailty are at risk of TTS. Right ventricular pacing threshold is acutely affected by TTS and improves over time.

Seat belts-related behaviors in car drivers with cardiac implantable electronic devices.

BACKGROUND: Seat belt use is the single most effective means of reducing fatal injuries in road traffic accidents. The presence of a cardiac implantable electronic device (CIED) might influence seat belt-related behaviors due to the physical proximity of the seat belt and left subclavian area in which the device is usually implanted. Understanding the underlying mechanisms of improper seat belt use may improve safety of these patients. METHODS: We performed a prospective study using a structured questionnaire with 120 CIED recipients (age, 63.9 ± 10.9 years) attending a pacing outpatient clinic. All study participants were active drivers and predominantly male. The majority of patients (79%) had undergone high-energy device implantation. RESULTS: We found that 18% of study participants do not fasten seat belts on a regular basis or use the seat belt in an atypical fashion (such as under the armpit). Moderate or high level of discomfort from the interaction between seat belt and CIED was present in 27%, while more than half (51%) were afraid of seat belt-induced CIED damage. In multifactorial analysis, we found the following independent predictors of improper seat belt use: (1) at least moderate level of discomfort at the CIED site (P = 0.02); (2) fear of CIED damage (P = 0.009); and (3) irregular seat belt use prior to CIED implantation (P = 0.037). CONCLUSIONS: Improper seat belt-related behaviors are common in CIED recipients. They arise from previous habits and from CIED-related physical and psychological factors. Patients' education regarding the importance and safety of proper seat belt use is a priority.

Discussion about different cut-off values of conventional hamstring-to-quadriceps ratio used in hamstring injury prediction among professional male football players.

OBJECTIVE: To measure the sensitivity and specificity of differences cut-off values for isokinetic Hcon/Qcon ratio in order to improve the capacity to evaluate (retrospectively) the injury of hamstring muscles in professional soccer screened with knee isokinetic tests. DESIGN: Retrospective study. METHODS: Medical and biomechanical data of professional football players playing for the same team for at least one season between 2010 and 2016 were analysed. Hamstring strain injury cases and the reports generated via isokinetic testing were investigated. Isokinetic concentric(con) hamstring(H) and quadriceps(Q) absolute strength in addition with Hcon/Qcon ratio were examined for the injured versus uninjured limbs among injured players, and for the injured and non-injured players. 2 x 2 contingency table was used for comparing variables: predicted injured or predicted uninjured with actual injured or actual uninjured. Sensitivity, specificity, accuracy, positive and negative predictive values, and positive and negative likelihood ratio were calculated for three different cut-off values (0.47 vs. 0.6 vs. 0.658) to compare the discriminative power of an isokinetic test, whilst examining the key value of Hcon/Qcon ratio which may indicate the highest level of ability to predispose a player to injury. McNemar's chi2 test with Yates's correction was used to determine agreement between the tests. PQStat software was used for all statistical analysis, and an alpha level of p <0.05 was used for all statistical comparisons. RESULTS: 340 isokinetic test reports on both limbs of 66 professional soccer players were analysed. Eleven players suffered hamstring injuries during the analysed period. None of these players sustained recurrence of hamstring injury. One player sustained hamstring strain injury on both legs, thus the total number of injuries was 12. Application of different cut-off values for Hcon/Qcon significantly affected the sensitivity and specificity of isokinetic test used as a tool for muscle injury detection. The use of 0.47 of Hcon/Qcon as a discriminate value resulted in significantly lower sensitivity when compared to 0.658 threshold (sensitivity of 16.7% vs. 91.7%, respectively; t = 6.125,p = 0.0133). Calculated values of specificity (when three different cut-off were applied) were also significantly different. Threshold of 0.6 of Hcon/Qcon resulted with significantly lower specificity compared to 0.47 value (specificity of 46.9% vs. 94.5%, respectively; t = 153.0,p<0.0001), and significantly higher specificity when compared to 0.658 (specificity of 46.9% vs. 24.1%, respectively; t = 229.0, p<0.0001). CONCLUSION: The use of different cut-off values for Hcon/Qcon significantly affected the sensitivity and specificity of isokinetic testing. The interpretation of usefulness of isokinetic test as a screening tool in a group of male professional football players to predict hamstring injury occurrence within the next 12 months might be therefore significantly biased due to the different threshold values of Hcon/Qcon. Using one "normative" value as a cut-off (e.g. 0.47 or 0.60, or 0.658) to quantify soccer players (or not) to the group with a higher risk of knee injury might result in biased outcomes due to the natural strength asymmetry that is observed within the group of soccer players.