Influence of Pathophysiological Patterns of Coronary Artery Disease on Immediate Percutaneous Coronary Intervention Outcomes.

BACKGROUND: Diffuse coronary artery disease (CAD) impacts the safety and efficacy of percutaneous coronary intervention (PCI). Pathophysiological CAD patterns can be quantified using fractional flow reserve (FFR) pullbacks incorporating the pullback pressure gradient (PPG) calculation. This study aimed to establish the capacity of PPG to predict optimal revascularisation and procedural outcomes. METHODS: This prospective, investigator-initiated, single-arm, multicentre study enrolled patients with at least one epicardial lesion with an FFR ≤ 0.80 scheduled for PCI. Manual FFR pullbacks were employed to calculate PPG. The primary outcome of optimal revascularisation was defined as a post-PCI FFR ≥ 0.88. RESULTS: 993 patients with 1044 vessels were included. The mean FFR was 0.68 ± 0.12, PPG 0.62 ± 0.17, and post-PCI FFR 0.87 ± 0.07. PPG was significantly correlated with the change in FFR after PCI (r=0.65, 95% CI 0.61-0.69, p<0.001) and demonstrated excellent predicted capacity for optimal revascularisation (AUC 0.82, 95% CI 0.79-0.84, p<0.001). Conversely, FFR alone did not predict revascularisation outcomes (AUC 0.54, 95% CI 0.50-0.57). PPG influenced treatment decisions in 14% of patients, redirecting them from PCI to alternative treatment modalities. Periprocedural myocardial infarction occurred more frequently in patients with low PPG (<0.62) compared to those with focal disease (OR 1.71, 95% CI: 1.00-2.97). CONCLUSIONS: Pathophysiological CAD patterns distinctly affect the safety and effectiveness of PCI. The PPG showed an excellent predictive capacity for optimal revascularisation and demonstrated added value compared to a FFR measurement.

Upper extremity versus lower extremity for secondary access during transcatheter aortic valve implantation: rationale and design of the randomised TAVI XS trial.

BACKGROUND: During transcatheter aortic valve implantation (TAVI), secondary access is required for angiographic guidance and temporary pacing. The most commonly used secondary access sites are the femoral artery (angiographic guidance) and the femoral vein (temporary pacing). An upper extremity approach using the radial artery and an upper arm vein instead of the lower extremity approach using the femoral artery and femoral vein may reduce clinically relevant secondary access site-related bleeding complications, but robust evidence is lacking. TRIAL DESIGN: The TAVI XS trial is a multicentre, randomised, open-label clinical trial with blinded evaluation of endpoints. A total of 238 patients undergoing transfemoral TAVI will be included. The primary endpoint is the incidence of clinically relevant bleeding (i.e. Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding) of the randomised secondary access site (either diagnostic or pacemaker access, or both) within 30 days after TAVI. Secondary endpoints include time to mobilisation after TAVI, duration of hospitalisation, any BARC type 2, 3 or 5 bleeding, and early safety at 30 days according to Valve Academic Research Consortium­3 criteria. CONCLUSION: The TAVI XS trial is the first randomised trial comparing an upper extremity approach to a lower extremity approach with regard to clinically relevant secondary access site-related bleeding complications. The results of this trial will provide important insights into the safety and efficacy of an upper extremity approach in patients undergoing transfemoral TAVI.

Potential effects of the hydrostatic pressure gradient on hyperemic and nonhyperemic pressure ratios.

When measuring hyperemic and nonhyperemic pressure ratios with traditional sensor-tipped wires, the inevitable hydrostatic pressure gradient (HPG) may influence treatment decisions. This study aimed to simulate and analyze the effect of a hydrostatic pressure gradient on different indices of functional lesion severity. A hypothetical Pd-Pa height difference and subsequent hydrostatic pressure gradient based on previous literature was applied to the pressure measurements from the CONTRAST study. The effect on three indices of functional lesion severity (FFR, Pd/Pa, and dPR) was assessed and possible reclassifications in functional significance by the different indices were analyzed. In 602 pressure tracings, simulated hydrostatic pressure gradients led to an absolute change in Pd of 3.18 ± 1.30 mmHg, resulting in an overall increase in FFR, Pd/Pa, and dPR of 0.02 ± 0.04 for all indices (P = 0.69). Reclassification due to the hydrostatic pressure gradient when using dichotomous cutoff values occurred in 13.4, 22.3, and 20.6% for FFR, Pd/Pa, and dPR, respectively. The effect of hydrostatic pressure gradient correction differed among the coronary arteries and was most pronounced in the left anterior descending. When considering the gray zone for the different functional indices, the hydrostatic pressure gradient resulted in reclassification in only one patient out of the complete patient population (1/602; 0.17%). The hydrostatic pressure gradient can influence functional lesion assessment when using dichotomous cutoff values. When taking the gray zone into account, its effect is limited.NEW & NOTEWORTHY This study systematically simulated the effect of hydrostatic pressure gradients (HPG) on real-world hyperemic and nonhyperemic pressure ratios, showing correction for HPG leads to reclassification in functional significance from 13.4 to 22.3% for different functional indices. This was most pronounced in nonhyperemic pressure ratios. A new pressure guidewire (Wirecath) is unaffected by HPG. The ongoing PW-COMPARE study (NCT04802681) prospectively analyzes the magnitude and importance of HPG by simultaneous FFR measurements.

Rationale and design of the pullback pressure gradient (PPG) global registry.

INTRODUCTION: Diffuse disease has been identified as one of the main reasons leading to low post-PCI fractional flow reserve (FFR) and residual angina after PCI. Coronary pressure pullbacks allow for the evaluation of hemodynamic coronary artery disease (CAD) patterns. The pullback pressure gradient (PPG) is a novel metric that quantifies the distribution and magnitude of pressure losses along the coronary artery in a focal-to-diffuse continuum. AIM: The primary objective is to determine the predictive capacity of the PPG for post-PCI FFR. METHODS: This prospective, large-scale, controlled, investigator-initiated, multicenter study is enrolling patients with at least 1 lesion in a major epicardial vessel with a distal FFR ≤ 0.80 intended to be treated by PCI. The study will include 982 subjects. A standardized physiological assessment will be performed pre-PCI, including the online calculation of PPG from FFR pullbacks performed manually. PPG quantifies the CAD pattern by combining several parameters from the FFR pullback curve. Post-PCI physiology will be recorded using a standardized protocol with FFR pullbacks. We hypothesize that PPG will predict optimal PCI results (post-PCI FFR ≥ 0.88) with an area under the ROC curve (AUC) ≥ 0.80. Secondary objectives include patient-reported and clinical outcomes in patients with focal vs. diffuse CAD defined by the PPG. Clinical follow-up will be collected for up to 36 months, and an independent clinical event committee will adjudicate events. RESULTS: Recruitment is ongoing and is expected to be completed in the second half of 2023. CONCLUSION: This international, large-scale, prospective study with pre-specified powered hypotheses will determine the ability of the preprocedural PPG index to predict optimal revascularization assessed by post-PCI FFR. In addition, it will evaluate the impact of PPG on treatment decisions and the predictive performance of PPG for angina relief and clinical outcomes.

Angiographic predictors of aberrant circumflex artery during cardiac catheterization.

OBJECTIVES: To identify angiographic predictors of aberrant left circumflex artery (LCx) by comparing left main (LM) length and bifurcation angle between patients with aberrant LCx and normal anatomy. BACKGROUND: Failure to recognize aberrant LCx during a cardiac catheterization may hamper correct diagnosis, delay intervention in acute coronary syndromes, and result in increased contrast volume, radiation exposure, and infarct size. METHODS: We retrospectively analyzed angiograms of aberrant LCx patients and normal anatomy matched controls, in three-participating centers. LM-length, bifurcation angle between the left anterior descending (LAD) and the first non-LAD branch of the LM, and procedural data were compared. RESULTS: Between 2003 and 2020, 136 patients with aberrant LCx and 135 controls were identified. More catheters (2.4 ± 0.6 vs. 2.2 ± 0.9, p = 0.009), larger contrast volumes (169 ± 94 ml vs. 129 ± 68 ml, p < 0.0005), and prolonged fluoroscopy time (652.9 ± 623.7 s vs. 393.1 ± 332.1 s, p < 0.0005), were required in the aberrant LCx-group compared with controls. Patients with aberrant LCx had a longer LM-length and a more acute bifurcation angle, both in caudal and cranial views, compared with controls (24.7 ± 8.1 vs. 10.8 ± 4.5 mm, p < 0.0005 and 26.7 ± 7.4 vs. 12 ± 5.5 mm, p < 0.0005, respectively, and 45.2° ± 12° vs. 88.8° ± 23°, p < 0.0005 and 51.9° ± 21° vs. 68.2° ± 28.3°, p < 0.0005, respectively). In ROC analysis, LM-length showed the best diagnostic accuracy for detecting aberrant LCx. In multiple logistic regression analysis, a cranially measured LM-length > 17.7 mm was associated with a 5.3 times greater probability of predicting aberrant LCx [95% CI (3.4-8.1), p < 0.0001]. CONCLUSIONS: Our study suggests that a long LM-length and an acute bifurcation angle can indicate the presence of aberrant LCx. We present a practical algorithm for its rapid identification.

The Allegra transcatheter heart valve: Short term results from a multicenter registry.

OBJECTIVES: We aimed to determine the safety and efficacy of the Allegra transcatheter heart valve (THV) for the treatment of severe aortic valve stenosis in a large patient population treated under real-world conditions. BACKGROUND: The Allegra is a novel self-expanding THV with supra-annular bovine leaflets. The valve is available in three different sizes (23, 27, and 31 mm), all are delivered through an 18F sheath. METHODS: Consecutive patients undergoing TAVR with the Allegra THV were enrolled in a multicenter-registry. Data were collected throughout initial hospital-stay and at 30-day follow-up. Clinical endpoints were defined according to the updated definitions of the Valve-Academic-Research-Consortium. RESULTS: This registry included 255 patients (mean age 83 ± 6 years, 48% women) from four European centers. Median European System for Cardiac Operative Risk Evaluation II score (EuroSCORE II) was 3.3% (IQR 1.9-5.8%). Acute device success was 95.7%. The remaining 11 patients had either moderate paravalvular regurgitation immediately after the procedure (7 patients) or the device could not be optimal positioned requiring implantation of a second THV (4 patients). Major vascular complications and major/life-threatening bleedings occurred in 10 (3.9%) and 12 (4.7%) patients, respectively. At 30 day follow-up, mean effective orifice area was 2.2 ± 0.5 cm2 , mean gradient was 6.9 ± 3.8 mmHg, 7 (3.3%) patients had more than mild paravalvular leakage, 3 patients (1.2%) had died, 6 patients (2.4%) had a stroke and 30 (12.8%) patients had required implantation of a new permanent pacemaker. CONCLUSIONS: Transfemoral implantation of the Allegra THV resulted in favorable clinical and echocardiographic outcomes during hospitalization and short-term follow up.

Intra-aortic balloon pump counterpulsation in extensive myocardial infarction with persistent ischemia: The SEMPER FI pilot study.

OBJECTIVES: This study aimed to prospectively investigate intra-aortic balloon pump counterpulsation (IABP) support in large myocardial infarction complicated by persistent ischemia after primary percutaneous coronary intervention (PCI). BACKGROUND: Use of IABP is suggested to be effective by increasing diastolic aortic pressure, thereby improving coronary blood flow. This can only be expected with exhausted coronary autoregulation, typical in acute myocardial infarction complicated by persistent ischemia. In this situation, augmented diastolic pressure is expected to increase myocardial oxygenation. METHODS: One hundred patients with large STEMI complicated by persistent ischemia after primary PCI were randomized to treatment with or without IABP therapy on top of standard care. IABP support was initiated following primary PCI, immediately after inclusion. Primary end point was all-cause mortality, need for (additional) mechanical hemodynamic support, or readmission for heart failure within 6 months. RESULTS: Mean age was 63 ± 10 years, 76% were male. Mean systolic and diastolic blood pressure were 120 ± 25 mmHg and 73 ± 17 mmHg. Mean heart rate was 75 ± 18 mmHg. Before PCI, mean summed ST-deviation was 21 ± 8 mm with only minimal ST-resolution after PCI. One patient in the IABP group reached the primary end point versus four patients in the control group (2% vs. 8%; p = 0.16). After primary PCI, resolution of ST-deviation was significantly more pronounced in the IABP group (73 ± 17%) compared to the control group (56 ± 26%; p < 0.01). CONCLUSIONS: In this pilot study, in patients with large STEMI and persistent ischemia after primary PCI, use of IABP showed a nonsignificant decrease in mortality, necessity for (additional) mechanical hemodynamic support or readmission for heart failure at 6 months, and resulted in more rapid ST-resolution.

Fractional flow reserve versus angiography for guidance of PCI in patients with multivessel coronary artery disease (FAME): 5-year follow-up of a randomised controlled trial.

BACKGROUND: In the Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) study, fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) improved outcome compared with angiography-guided PCI for up to 2 years of follow-up. The aim in this study was to investigate whether the favourable clinical outcome with the FFR-guided PCI in the FAME study persisted over a 5-year follow-up. METHODS: The FAME study was a multicentre trial done in Belgium, Denmark, Germany, the Netherlands, Sweden, the UK, and the USA. Patients (aged ≥ 18 years) with multivessel coronary artery disease were randomly assigned to undergo angiography-guided PCI or FFR-guided PCI. Before randomisation, stenoses requiring PCI were identified on the angiogram. Patients allocated to angiography-guided PCI had revascularisation of all identified stenoses. Patients allocated to FFR-guided PCI had FFR measurements of all stenotic arteries and PCI was done only if FFR was 0·80 or less. No one was masked to treatment assignment. The primary endpoint was major adverse cardiac events at 1 year, and the data for the 5-year follow-up are reported here. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00267774. FINDINGS: After 5 years, major adverse cardiac events occurred in 31% of patients (154 of 496) in the angiography-guided group versus 28% (143 of 509 patients) in the FFR-guided group (relative risk 0·91, 95% CI 0·75-1·10; p=0·31). The number of stents placed per patient was significantly higher in the angiography-guided group than in the FFR-guided group (mean 2·7 [SD 1·2] vs 1·9 [1·3], p<0·0001). INTERPRETATION: The results confirm the long-term safety of FFR-guided PCI in patients with multivessel disease. A strategy of FFR-guided PCI resulted in a significant decrease of major adverse cardiac events for up to 2 years after the index procedure. From 2 years to 5 years, the risks for both groups developed similarly. This clinical outcome in the FFR-guided group was achieved with a lower number of stented arteries and less resource use. These results indicate that FFR guidance of multivessel PCI should be the standard of care in most patients. FUNDING: St Jude Medical, Friends of the Heart Foundation, and Medtronic.

Safety and feasibility of local myocardial hypothermia.

BACKGROUND: In ST-elevation myocardial infarction (STEMI), reduction in time to reperfusion of the occluded coronary artery reduces infarct size. In animal models, an additional reduction of infarct size was observed when hypothermia was induced before reperfusion, despite a longer ischemic time. However, several human studies did not corroborate this positive effect, which is believed to be in part due to the inability of systemic induced hypothermia to induce sufficient decrease of local myocardial temperature before reperfusion. Providing rapid local myocardial hypothermia by intracoronary infusion of saline before reperfusion in patients with STEMI may overcome this problem. In this study, we evaluate the safety and feasibility of providing rapid intracoronary myocardial hypothermia in patients undergoing intracoronary blood flow measurements based on thermodilution with continuous infusion of saline at room temperature. METHODS AND RESULTS: In 53 patients with stable angina (SA) and 20 patients with STEMI, a total of 215 measurements were performed. The measurements consisted of continuous selective intracoronary infusion of saline at room temperature with rates between 10 ml/min and 30 ml/min. Temperature changes compared to initial blood temperature (Tb ) were measured at the tip of the infusion catheter (Ti ) and distally in the coronary artery (Td ). In patients with SA, Ti was -5.65 ± 1.41°C (range -9.27 to -2.28) and Td was -0.78 ± 0.51°C (range -3.27 to -0.23°C). In patients with STEMI, Ti was -7.45 ± 0.51°C (range -8.21 to -6.56) and Td was -1.37 ± 0.82°C (range -4.62 to -0.74°C). In all patients, steady-state intracoronary hypothermia was achieved within 15 sec and could be maintained without noticeable complications. CONCLUSION: This study demonstrates the safety and feasibility of inducing intracoronary hypothermia by selective infusion of saline at room temperature in patients with SA and STEMI. Steady-state hypothermia could be achieved and maintained quickly, easily, and safely using common PCI techniques. Therefore, our findings warrant further studies to the use of intracoronary hypothermia to enhance myocardial salvage in acute myocardial infarction.

Deferral vs. performance of percutaneous coronary intervention of functionally non-significant coronary stenosis: 15-year follow-up of the DEFER trial.

AIMS: Stenting an angiographically intermediate but functionally non-significant stenosis is controversial. Nevertheless, it has been questioned if deferral of a functionally non-significant lesion on the basis of fractional flow reserve (FFR) measurement, is safe, especially on the long term. Five-year follow-up of the DEFER trial showed that outcome after deferral of percutaneous coronary intervention (PCI) of an intermediate coronary stenosis based on FFR ≥ 0.75 is excellent and was not improved by stenting. The aim of this study was to investigate the validity of this position on the very long term. METHODS AND RESULTS: In 325 patients scheduled for PCI of an intermediate stenosis, FFR was measured just before the planned intervention. If FFR was ≥0.75, patients were randomly assigned to deferral (Defer group; n = 91) or performance (Perform group; n = 90) of PCI. If FFR was <0.75, PCI was performed as planned (Reference group; n = 144). Clinical follow-up was 15 years. There were no differences in baseline clinical characteristics between the randomized groups. Complete 15-year follow-up was obtained in 92% of patients. After 15 years of follow-up, the rate of death was not different between the three groups: 33.0% in the Defer group, 31.1% in the Perform group, and 36.1% in the Reference group (Defer vs. Perform, RR 1.06, 95% CI: 0.69-1.62, P = 0.79). The rate of myocardial infarction was significantly lower in the Defer group (2.2%) compared with the Perform group (10.0%), RR 0.22, 95% CI: 0.05-0.99, P = 0.03. CONCLUSION: Deferral of PCI of a functionally non-significant stenosis is associated with a favourable very long-term follow-up without signs of late 'catch-up' phenomenon.

Variability of fractional flow reserve according to the methods of hyperemia induction.

OBJECTIVES: We performed this study to evaluate the variability of fractional flow reserve (FFR) values which were measured from various methods of hyperemia induction. BACKGROUND: Concerns have been raised regarding the variability of FFR due to different routes for hyperemic agent administration and different hyperemic agents targeting different receptors to induce maximal hyperemia. METHODS: A total of 656 intermediate coronary lesions from 628 patients with coronary artery disease were analyzed. Among them, 238 lesions underwent FFR measurement with hyperemia induced by both intravenous (IV) and intracoronary (IC) adenosine administration, 318 by IV adenosine/adenosine triphosphate (ATP) and IC nicorandil injection, and 100 by IV adenosine and regadenoson infusion. RESULTS: Excellent correlation and close classification agreement (FFR ≤ 0.80) were observed between IV vs. IC adenosine (r = 0.980, CA = 92.9%, Cohen's Kappa = 0.887, P < 0.001), between IV adenosine/ATP vs. IC nicorandil (r = 0.962, CA = 91.2%, Cohen's Kappa = 0.817, P < 0.001), and between IV adenosine vs. regadenoson (r = 0.990, CA = 100%, Cohen's Kappa = 1.000, P < 0.001). When changes in blood pressure (ΔBP) or heart rate (ΔHR) were compared with changes in FFR (ΔFFR) between IV adenosine/ATP and IC nicorandil administration, there were no significant correlations between ΔBP and ΔFFR nor between ΔHR and ΔFFR (r = -0.122, P = 0.076; r = 0.036, P = 0.605, respectively). CONCLUSIONS: This study suggests that the measurement of FFR is reproducible regardless of the hemodynamic changes, hyperemic agents used, or the route of administration.

Intra-Aortic Balloon Pump Support in the Isolated Beating Porcine Heart in Nonischemic and Ischemic Pump Failure.

The blood pressure changes induced by the intra-aortic balloon pump (IABP) are expected to create clinical improvement in terms of coronary perfusion and myocardial oxygen consumption. However, the measured effects reported in literature are inconsistent. The aim of this study was to investigate the influence of ischemia on IABP efficacy in healthy hearts and in shock. Twelve slaughterhouse porcine hearts (hearts 1-12) were connected to an external circulatory system, while physiologic cardiac performance was restored. Different clinical scenarios, ranging from healthy to cardiogenic shock, were simulated by step-wise administration of negative inotropic drugs. In hearts 7-12, severe global myocardial ischemia superimposed upon the decreased contractile states was created. IABP support was applied in all hearts under all conditions. Without ischemia, the IABP induced a mild increase in coronary blood flow and cardiac output. These effects were strongly augmented in the presence of persisting ischemia, where coronary blood flow increased by 49 ± 24% (P < 0.01) and cardiac output by 17 ± 6% (P < 0.01) in case of severe pump failure. As expected, myocardial oxygen consumption increased in case of ischemia (21 ± 17%; P < 0.01), while it slightly decreased without (-3 ± 6%; P < 0.01). In case of progressive pump failure due to persistent myocardial ischemia, the IABP increased hyperemic coronary blood flow and cardiac output significantly, and reversed the progressive hemodynamic deterioration within minutes. This suggests that IABP therapy in acute myocardial infarction is most effective in patients with viable myocardium, suffering from persistent myocardial ischemia, despite adequate epicardial reperfusion.

Myocardial Infarction and Coronary Anomalies in a 25-Year-Old Neurofibromatosis Type 1 Patient.

A 25-year-old male with neurofibromatosis type 1 presented with acute ST-segment elevation myocardial infarction. Coronary imaging revealed an aberrant right coronary anatomy, ectatic coronary arteries, and significant stenosis. Based on previous literature and clinical presentation, this case highlights the potential role of neurofibromatosis in the pathogenesis of coronary artery disease.

Fluid-filled versus sensor-tipped pressure guidewires for FFR and Pd/Pa measurement; PW-COMPARE study.

BACKGROUND: Fluid-filled pressure guidewires are unaffected by the previously inevitable hydrostatic pressure gradient (HPG). This study aimed to compare simultaneous pressure measurements with fluid-filled and sensor-tipped pressure guidewires. METHODS: Fifty patients underwent fractional flow reserve (FFR) and Pd/Pa measurement with a fluid-filled and a sensor-tipped pressure guidewire simultaneously. To assess maneuverability, patients were randomized with respect to which pressure guidewire was used to cross the lesion first. Lateral fluoroscopy was used to estimate height difference between catheter tip and distal wire position (and thus HPG). Agreement between pressure measurements was studied. RESULTS: Measurements were performed in LM (4% (n = 2)), LAD (44% (n = 22)), LCX (26% (n = 13)), and RCA (26% (n = 13)). Simultaneous pressure measurements showed excellent agreement (mean FFR difference - 0.01 ± 0.03 (r = 0.959, p < 0.001), mean Pd/Pa difference - 0.01 ± 0.04 (r = 0.929, p < 0.001)). FFR was ≤0.80 in 42.6% (n = 20) with fluid-filled FFR measurements versus 46.8% (n = 22) by sensor-tipped FFR measurements. Mean height difference was 15 ± 34 mm, and strongly dependent on the coronary artery (LAD 45 ± 10 mm, LCX -23 ± 16 mm, RCA -13 ± 17 mm). There was a strong correlation between height difference and difference in pressure ratios between sensor-tipped and fluid-filled pressure guidewires (FFR r = -0.850, p < 0.001; Pd/Par = -0.641, p < 0.001). Largest FFR differences were present in the LAD (-0.04 ± 0.02). After HPG correction, mean difference between HPG-corrected sensor-tipped FFR and fluid-filled FFR was 0.00 ± 0.02, mean Pd/Pa difference was 0.01 ± 0.03. CONCLUSIONS: This study shows excellent overall correlation between FFR and Pd/Pa measurements with both pressure guidewires. Differences measured with fluid-filled and sensor-tipped pressure guidewires are vessel-specific and attributable to hydrostatic pressure gradients (NCT04802681).

Using Upper Arm Vein as Temporary Pacemaker Access Site: A Next Step in Minimizing the Invasiveness of Transcatheter Aortic Valve Replacement.

Background The femoral vein is commonly used as a pacemaker access site during transcatheter aortic valve replacement (TAVR). Using an upper arm vein as an alternative access site potentially causes fewer bleeding complications and shorter time to mobilization. We aimed to assess the safety and efficacy of an upper arm vein as a temporary pacemaker access site during TAVR. Methods We evaluated all patients undergoing TAVR in our center between January 2020 and January 2023. Upper arm, femoral, and jugular vein pacemaker access was used in 255 (45.8%), 191 (34.3%), and 111 (19.9%) patients, respectively. Clinical outcomes were analyzed according to pacemaker access in the overall population and in a propensity-matched population involving 165 upper arm and 165 femoral vein patients. Primary endpoint was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 pacemaker access site-related bleeding. Results In the overall population, primary endpoint was lowest for upper arm, followed by femoral and jugular vein access (2.4% vs. 5.8% vs. 10.8%, p = 0.003). Time to mobilization was significantly longer (p < 0.001) in the jugular cohort compared with the other cohorts. In the propensity-matched cohort, primary endpoint showed a trend toward lower occurrence in the upper arm compared with the femoral cohort (2.4% vs. 6.1%, p = 0.10). Time to mobilization was significantly shorter (480 vs. 1140 min, p < 0.001) in the upper arm cohort, with a comparable skin-to-skin time (83 vs. 85 min, p = 0.75). Cross-over from upper arm pacemaker access was required in 17 patients (6.3% of attempted cases via an upper arm vein). Conclusions Using an upper arm vein as a temporary pacemaker access site is safe and feasible. Its use might be associated with fewer bleeding complications and shorter time to mobilization compared with the femoral vein.

Results of systematic patient outcome monitoring: Does post-dilatation during angiography-guided percutaneous coronary intervention improve clinical outcomes?

OBJECTIVES: This study evaluates clinical outcomes after implementing a liberal post-dilatation strategy during PCI. BACKGROUND: Post-dilatation after percutaneous coronary intervention (PCI) is performed to achieve optimal stent expansion and reduce complications. However, its prognostic effects are unclear and conflicting. METHODS: This study is a pre-post-intervention analysis of two cohorts, before (2015-2017) and after (2018-2020) implementation of a liberal post-dilatation strategy. The primary end point consisted of major adverse cardiovascular events (MACE) at 30 days. Secondary end points consisted of the individual components of the primary end point as well as 1 year mortality and target vessel revascularization. RESULTS: A total of 10,153 patients were included: 5,383 in the pre-cohort and 4,770 in the post-cohort. The 30-day MACE was 5.00% in the pre-cohort and 4.09% in the post-cohort (p = 0.008; OR 0.75 (CI 0.61-0.93)). There was a significant difference between the pre- and post-cohort in 30-day mortality, respectively, 2.91% and 2.25% (p = .01; OR 0.70 (CI 0.53-0.93)), and MI at 30 days, 1.17% versus 0.59% (p = .003; OR 0.49 (CI 0.31-0.78)). At 1 year, there was a significant difference in mortality between the pre-cohort, 5.84%, and post-cohort, 5.19% (p = .02; OR 0.79 (CI 0.66-0.96)). CONCLUSIONS: A liberal post-dilatation strategy after PCI was associated with a significant decrease in 30-day MACE, 30-day MI, 30-day mortality, and 1-year mortality. Future studies are warranted to validate the causality between post-dilatation and improvement of clinical outcomes.