Periprocedural Vascular Complications Research Articles

Mortality rates in patients undergoing urgent versus elective transcatheter aortic valve replacement: a systematic review and meta-analysis

Abstract Background Patients with severe aortic stenosis (AoS) often present with acute heart failure and compensation, leading frequently to cardiogenic shock. Transcatheter Aortic Valve Replacement (TAVR) has been recently performed as a bailout treatment in such patients. The aim of our meta-analysis is to compare urgent TAVR to elective procedures. Methods We systematically screened three databases searching for studies comparing urgent versus elective TAVR. Primary endpoint is the 30-days mortality. Secondary endpoints included in-hospital mortality, device success, periprocedural vascular complications, 30-day stroke, 30-day acute kidney injury (AKI), permanent pacemaker implantation (PPM), moderate or severe paravalvular leakage and 30-day bleedings. Results Seventeen studies were included, with a total of 84,495 patients. Urgent TAVR was associated with an increased risk for 30-days mortality (RR: 2.53, 95% CI: 1.81 – 3.54), in-hospital mortality (RR: 2.67, 95% CI: 1.94 – 3.68), periprocedural vascular complications (RR: 1.91, 95% CI: 1.28 – 2.85) and AKI (RR: 2.83, 95% CI: 1.93 – 4.14), compared to elective procedure. No differences were observed in the rest secondary endpoints. Conclusions Urgent TAVR was associated with higher in-hospital and 30-day mortality, possibly driven by the increased incidence of AKI and vascular complications in urgent TAVR. The results highlight the importance of early TAVR in stable AoS patients.

Association of cardiac amyloidosis with periprocedural complications in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement: a systematic review and meta-analysis

Abstract Introduction Cardiac amyloidosis (CA) has been frequently observed in patients with aortic stenosis (AS). While transcatheter aortic valve replacement (TAVR) may be an option, the association of CA with risk of periprocedural complications has not been well evaluated. Purpose This study aimed to evaluate the association of CA with periprocedural complications after TAVR in patients with severe AS. Methods A literature search was performed for studies evaluating patients with severe AS undergoing AVR, comparing periprocedural safety endpoints for patients with and without CA. The primary endpoints were vascular complications and bradyarrhythmias post-TAVR requiring permanent pacemaker (PPM) implantation. Secondary endpoints included periprocedural acute kidney injury (AKI), cerebrovascular accidents (CVA), and major bleeding events. Endpoints were defined using the Valve Academic Research Consortium-2 criteria. The search was not restricted to time or publication status. Results 6 studies with 1,138 patients with severe AS (150 with CA, 988 without CA) met inclusion criteria. Mean age was 82 years, 52.4% were men, all except 1 study assessed only patients with ATTR CA. Echocardiographic mean aortic valve parameters included valve area of 0.718 cm2, mean gradient of 40.8, and peak velocity of 4.13 m/s. The mean left ventricular ejection fraction was 55.2%. The presence of CA was not associated with an increased risk of periprocedural vascular complications (OR 0.69, 95% CI 0.25-1.88; p=0.47). While a trend toward higher risk of periprocedural PPM implantation was observed in patients with CA, this finding did not reach statistical significance (OR 1.51; 95% CI 0.77-2.94; p=0.23). The presence of CA was not associated with increased risk of periprocedural AKI, CVA, or major bleeding (OR 1.3, 95% CI 0.32-5.3; p=0.72, OR 0.65, 95% CI 0.17-2.41; p=0.52; OR 0.55, 95% CI 0.16-1.87; p=0.34). Conclusion In the context of patients with severe AS undergoing TAVR, the presence of cardiac amyloidosis did not increase the risk of periprocedural complications, including vascular complications, AKI, CVA, or major bleeding. Although a trend toward a higher risk of bradyarrhythmias requiring PPM implantation was noted in patients with CA, further studies are warranted to confirm this observation. Overall, these findings contribute valuable insight into the safety profile of TAVR in the patients with CA.Figure 1Figure 2

Impella Versus Non-Impella for Nonemergent High-Risk Percutaneous Coronary Intervention

The benefit of mechanical circulatory support (MCS) with Impella (Abiomed, Inc., Danvers, MA) for high-risk percutaneous coronary intervention (HR-PCI) is uncertain. PROTECT III registry data showed improved outcomes with Impella compared to historical data (PROTECT II) but lacks a direct comparison to the HR-PCI cohort without Impella support. We retrospectively identified patients meeting PROTECT III inclusion criteria for HR-PCI and compared this group (NonIMP) to the outcomes data from the PROTECT III registry (IMP). Baseline differences were balanced using inverse propensity weighting (IPW). The co-primary outcome was major adverse cardiac events (MACE) in-hospital and at 90 days. A total of 283 high-risk patients who did not receive Impella support; 200 patients had at 90-day event ascertainment and were included in the IPW analysis and compared with 504 patients in the IMP group. After calibration, few residual differences remained between groups. The primary outcome was not different in-hospital (3.0% vs. 4.8%, p=0.403) but lower in NonIMP at 90 days (7.5% vs. 13.8%, p=0.033). Periprocedural vascular complications, bleeding, and transfusion rate were not different between groups; however, acute kidney injury occurred more frequently in the NonIMP group (10.5% vs. 5.4%, p=0.023). In conclusion, under identical HR-PCI inclusion criteria for Impella use in PROTECT III, an institutional non-Impella-supported HR-PCI cohort demonstrated similar MACE in-hospital but lower MACE at 90 days, while there was no signal for periprocedural harm with Impella use. These results do not support routine usage of Impella for HR-PCI patients.

Mortality Rates in Patients Undergoing Urgent Versus Elective Transcatheter Aortic Valve Replacement: A Meta-analysis.

Patients with severe aortic stenosis (AoS) often present with acute heart failure and compensation, frequently leading to cardiogenic shock. Transcatheter Aortic Valve Replacement (TAVR) has been recently performed as a bailout treatment in such patients. The aim of our meta-analysis is to compare urgent TAVR with elective procedures. We systematically screened three databases searching for studies comparing urgent vs elective TAVR. Primary endpoint is the 30-days mortality. Secondary endpoints included in-hospital mortality, device success, periprocedural vascular complications, 30-days stroke, 30-days acute kidney injury (AKI), permanent pacemaker implantation (PPM), moderate or severe paravalvular leakage, and 30-days bleeding. Seventeen studies were included, with a total of 84,495 patients. Urgent TAVR was associated with an increased risk for 30-days mortality [Risk Ratio (RR): 2.53, 95% Confidence Intervals (CI): 1.81-3.54)], in-hospital mortality (RR: 2.67, 95% CI: 1.94-3.68), periprocedural vascular complications (RR: 1.91, 95% CI: 1.28-2.85) and AKI (RR: 2.83, 95% CI: 1.93-4.14), compared with elective procedure. No differences were observed in the other secondary endpoints. Urgent TAVR was associated with higher in-hospital and 30-days mortality, possibly driven by the increased incidence of AKI and vascular complications in urgent TAVR. The results highlight the importance of early TAVR in stable AoS patients.

The impact of ultrasound-guided vascular access for catheter ablation of left atrial arrhythmias in a high-volume centre.

Vascular complications are a common occurrence during atrial fibrillation ablation. Observational studies indicate that the utilization of ultrasound (US)-guided puncture may decrease the incidence of vascular complications; however, its routine use is not established in many centres. Patients undergoing catheter ablation for atrial fibrillation were included sequentially. All patients receiving US-guided punctures were prospectively enrolled (US group), while patients who underwent the procedure with standard puncture technique served as control group (No-US group). Periprocedural vascular complications requiring intervention within 30days of the procedure were defined as the primary endpoint. A total of 599 patients (average age: 69 ± 11years, 62.9% male) were analysed. The incidence of vascular complications was lower with the US-guided puncture than with the anatomic landmark-guided puncture (14/299 [4.7%] vs. 27/300 [9%], p = 0.036). The US-guided vascular access significantly reduced the rate of false aneurysms (3/299 [1%] vs. 12/300 [4%], p = 0.019). In addition, the occurrence of arteriovenous fistula (2/299 [0.7%] vs. 4/300 [1.3%], p = 0.686) and haematoma requiring treatment (9/299 [3%] vs. 11/300 [3.7%], p = 0.655) were also lower in the US group. US-guided puncture did not prolong the procedure time (mean procedure time: 57.48 ± 24.47min vs. 56.09 ± 23.36min, p = 0.478). Multivariate regression analysis identified female gender (OR 2.079, CI 95% 1.096-3.945, p = 0.025) and conventional vascular access (OR 2.079, CI 95% 1.025-3.908, p = 0.042) as predictors of vascular complications. The implementation of US-guided vascular access for left atrial catheter ablation resulted in a significant decrease of the overall vascular complication rate.

Clinical introduction of ultrasound-guided vascular access in catheter ablation of left atrial arrhythmias

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Vascular complications are a common occurrence during atrial fibrillation ablation. Observational studies show that the incidence of vascular complications can be reduced by using ultrasound (US)-guided puncture, however its routine use is not established in many centers. Purpose To compare the rate of vascular complications between ultrasound-guided and conventional anatomic landmark-guided vascular access during catheter ablation of left atrial arrhythmias. Methods Patients undergoing catheter ablation for atrial fibrillation were included sequentially. All patients receiving US-guided puncture were prospectively enrolled group A, while patients who underwent the procedure with standard puncture technique served as control group B. The primary endpoint were periprocedural vascular complications requiring intervention within 30 days of the procedure Results 599 patients (average age: 68 ± 11 years, 63,1% male) were analyzed, 299 in group A and 300 in group B. Demographic and clinical baseline characteristics were comparable between the two groups, except higher prevalence of pre-existing Diabetes mellitus in group A (14,7% vs. group B: 8,7%, p=0.022). The majority of patients were treated with radiofrequency ablation (51,5%), followed by pulsed-field ablation (20,4%) and cryoballoon (18,7%). Other ablation techniques were laserballoon and radiofrequency balloon ablation. The overall rate of vascular complications was lower with the ultrasound-guided puncture than the anatomic landmark-guided puncture (14/299 4,7% vs. 27/300 9%, p=0.036). The ultrasound-guided puncture resulted in a significantly reduced rate of false aneurysms (3/299 1% vs. 12/300 4%, p=0.019). In addition, arteriovenous fistula (2/0,7% vs. 4/1,3%, p=0.414) and hematoma requiring treatment (9/299 3% vs. 11/300 3,7%, p=0.655) were also lower in group A. Conclusion The use of ultrasound-guided vascular access for catheter ablation resulted in a significant reduction of the overall vascular complication rate.

Abstract 12187: Transcatheter versus Surgical Aortic Valve Replacement With Concurrent Coronary Revascularization: A Systematic Review and Meta-Analysis

Objective: This meta-analysis aimed to evaluate outcomes of transcatheter aortic valve replacement (TAVR) with percutaneous coronary intervention (PCI) versus surgical aortic valve replacement (SAVR) with coronary artery bypass grafting (CABG). Methods: MEDLINE and EMBASE were searched through November 2021 to identify studies comparing TAVR+PCI and SAVR+CABG for severe aortic stenosis with concurrent coronary artery disease. Outcomes of interest were long-term all-cause mortality, repeat coronary intervention, rehospitalization, myocardial infarction, and stroke during follow-up, and 30-day periprocedural outcomes. Results: Two randomized controlled trials and six observational studies including a total of 104,220 patients (TAVR+PCI, n = 5,004; SAVR+CABG, n = 99,226) were included. Median follow-up periods ranged from one to three years. TAVR+PCI was associated with higher all-cause mortality and coronary reintervention during follow-up period (Hazard Ratio [HR], 1.35; 95% confidence interval [CI], 1.11-1.65; p = 0.003, HR, 4.14; 95% CI, 1.74-9.86; p = 0.001, respectively), 30-day permanent pacemaker implantation rate (Odds Ratio [OR], 3.79; 95% CI, 1.61-8.95; p = 0.002), and periprocedural vascular complications (OR 6.97; 95% CI, 1.85-26.30; p = 0.004). In contrast, TAVR+PCI was associated with a lower rate of 30-day acute kidney injury (OR, 0.32; 95% CI, 0.20-0.50; p = 0.0001). Rehospitalization, myocardial infarction, stroke during follow-up, and other periprocedural outcomes including 30-day mortality were similar in both groups. Conclusions: In patients with severe aortic stenosis and coronary artery disease, TAVR+PCI was associated with higher all-cause mortality at follow-up compared with SAVR+CABG. Heart team approach to assess TAVR candidacy remains imperative.

RailTracking: A Novel Technique to Overcome Difficult Anatomy During Transradial Approach.

We aim to investigate the safety and efficacy of a new technique, "RailTracking," in the management of challenging transradial routes during percutaneous coronary interventions (PCI). The transradial access (TRA) currently represents the access site of choice in PCI, but complex anatomy could lead to complications and access-site crossover. The assisted-tracking techniques described in the past (such as balloon-assisted tracking and pigtail-assisted tracking) are based on the concept of a "guiding tapered tip" to improve trackability. The RailTracking technique creates a tapered catheter tip using a dedicated device. We collected patient data from January 2021 to January 2022 in 2 high-volume centers using the RailTracking technique as a bail-out solution. A prospective analysis of the anatomical characteristics and outcomes of the study population was performed. Seventy-seven patients were included in the study. All patients presented with challenging anatomies; 35.1% of the patients (n = 27) had small radial arteries, 19.5% (n = 15) had significant radial tortuosity, 2.6% (n = 2) had significant brachial tortuosity, 2.6% (n = 2) had subclavian tortuosity, and 1.29% (n = 1) had a critical subclavian lesion. In addition, 38.9% presented with severe radial spasm. The procedural success rate of the RailTracking technique was 98.7% (76/77 patients). The only case of failure presented with calcifications and a critical lesion in the subclavian artery. However, no periprocedural vascular complications occurred. This new technique appears safe, with a radial artery occlusion rate of 3.89% (n = 3) at 1-month follow-up. The new RailTracking technique improves catheter crossing in challenging anatomies and seems safe and effective in cases of failure with currently available approaches.

Complete transcatheter versus surgical approach to aortic stenosis with coronary artery disease: A systematic review and meta-analysis

ObjectiveThis meta-analysis aimed to evaluate outcomes of transcatheter aortic valve replacement (TAVR) with percutaneous coronary intervention (PCI) versus surgical aortic valve replacement (SAVR) with coronary artery bypass grafting (CABG). MethodsThe MEDLINE, EMBASE, and Cochrane Library databases were searched through November 2021 to identify studies comparing TAVR + PCI and SAVR + CABG for severe aortic stenosis with concurrent coronary artery disease. Outcomes of interest were all-cause mortality, repeat coronary intervention, rehospitalization, myocardial infarction, and stroke during follow-up, and 30-day periprocedural outcomes. ResultsTwo randomized controlled trials and 6 observational studies including a total of 104,220 patients (TAVR + PCI, n = 5004; SAVR + CABG, n = 99,216) were included. The weighted mean follow-up period was 30.2 months. TAVR + PCI was associated with greater all-cause mortality and coronary reintervention during follow-up period (hazard ratio, 1.35; 95% confidence interval [CI], 1.11-1.65; P = .003, hazard ratio, 4.14; 95% CI, 1.74-9.86; P = .001, respectively), 30-day permanent pacemaker implantation rate (odds ratio [OR], 3.79; 95% CI, 1.61-8.95; P = .002), and periprocedural vascular complications (OR, 6.97; 95% CI, 1.85-26.30; P = .004). In contrast, TAVR + PCI was associated with a lower rate of 30-day acute kidney injury (OR, 0.32; 95% CI, 0.20-0.50; P = .0001). Rehospitalization, myocardial infarction, stroke during follow-up, and other periprocedural outcomes including 30-day mortality were similar in both groups. ConclusionsIn patients with severe aortic stenosis and coronary artery disease, TAVR + PCI was associated with greater all-cause mortality at follow-up compared with SAVR + CABG. Heart Team approach to assess TAVR candidacy remains imperative.

Comparison of In-Hospital Outcomes of Patients With-Versus-Without Ischemic Cardiomyopathy Undergoing Left Ventricular Assist Device Placement

The objective of this study was to evaluate the impact of heart failure (HF) etiology (ischemic cardiomyopathy [ICM] versus nonischemic cardiomyopathy) on in-hospital outcomes in patients undergoing left ventricular assist device (LVAD) placement using the Nationwide Inpatient Sample database. We identified patients who underwent LVAD placement from 2011 to 2014. The primary end point was the effect of ICM on in-hospital mortality. Secondary end points included periprocedural vascular complications requiring surgery, postoperative myocardial infarction, stroke, and hemorrhage requiring transfusion. We also assessed length of stay and cost of hospitalization. A mixed effects logistic model was used for clinical end points and a linear mixed model was used for cost and length of stay. In 3,511 patients who underwent LVAD placement (23.32% women and 56.23 ± 13.51 years old), the incidence of ICM was 53.5%. After adjusting for patient- and hospital-level characteristics, ICM was not found to influence in-hospital mortality (odds ratio [OR] 0.98, 95% confidence interval [CI] 0.78 to 1.23). ICM was associated with an increased risk in periprocedural hemorrhage requiring transfusion (OR 1.29, 95% CI 1.08 to 1.53), vascular complications requiring surgery (OR 1.58 95% CI 1.10 to 2.28) and postoperative ST-segment myocardial infarction (OR 7.38 95% CI 5.33 to 10.24). In conclusion, ICM did not impact in-hospital mortality in patients who underwent LVAD placement but was associated with increased vascular complications, hemorrhage requiring transfusion, and postoperative myocardial infarction.

Abstract 20126: Associations of Known Complications of Transcatheter Implantation of Balloon-expandable Edwards-Sapien XT Aortic Valves With Peri-procedural Mortality - An Insight From the 2014-2015 Reports From the FDA MAUDE Database

Background: Transcatheter implantation of aortic valves (TAVR) has revolutionized the management of severe aortic stenosis. However, specific complications have been noted with the valves. Details of such were sought from the US Food and Drug Administration (FDA) maintained MAUDE database which houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers. Methods: A detailed search was conducted in PubMed, Cochrane Library, EMBASE and CINAHL to identify adverse events reported with the implantation of the Edwards-Sapien XT valves. Then the FDA MAUDE database was queried from June 2014 to May 2015 to identify prevalence of the same complications as reported to the FDA. Individual patient reports were identified and relevant data on such complications were abstracted. Finally, mortality outcomes from such patients were abstracted, and associations of these for each individual reported complication were identified in a multivariate logistic regression model. Results: FDA MAUDE revealed 730 unique reports of complications with the first- generation Edwards-Sapien valves. A total of 106 patients died peri-procedurally. The complications most strongly associated with peri-procedural mortality were development of peri-procedural vascular complications, need for permanent pacemaker, renal failure, atrial fibrillation, stroke, need for surgical valve implantation and need for valve in valve procedure. (Table 1) Conclusions: Specific complications with the new Edwards XT valves were strongly associated with mortality, and focused strategies to mitigate these complications may improve outcomes with future generations of this exciting new technology.

Transradial access for renal artery intervention.

Percutaneous interventional procedures in the renal arteries are usually performed using a femoral or brachial vascular access. The transradial approach is becoming more popular for peripheral interventions, but limited data exists for renal artery angioplasty and stenting. We have analyzed the clinical, angiographic and technical results of renal artery stenting performed from radial artery access between 2012 and 2013. The radial artery anatomy was identified with aortography using 100 cm pig tail catheter. After engagement of the renal artery ostium with a 6F Multipurpose or 6F JR5 guiding catheter, the stenosis was passed with a 0.014" guidewire followed by angioplasty and stent implantation. In 27 patients (mean age: 65.4 ± 9.17) with hemodynamically relevant renal artery stenosis (mean diameter stenosis: 77.7 ± 10.6%; right, n = 7; left, n = 20), interventional treatment with angioplasty and stenting was performed using a left (n = 3) or right (n = 24) radial artery access. Direct stenting was successfully performed in 13 (48%) cases, and predilatations were required in ten cases 10 (37%). Primary technical success (residual stenosis <30%) could be achieved in all cases. The mean contrast consumption was 119 ± 65 ml and the mean procedure time was 30 ± 8.2 min. There were no major periprocedural vascular complications and in one patient transient creatinine level elevation was observed (3.7%). In one patient asymptomatic radial artery occlusion was detected (3.7%). Transradial renal artery angioplasty and stenting is technically feasible and safe procedure.

Effect of gender differences on 1-year mortality after transcatheter aortic valve implantation for severe aortic stenosis: results from a multicenter real-world registry

The aim of this analysis is to examine the influence of gender differences on the outcome after transcatheter aortic valve implantation (TAVI) from a multicenter real-world registry in Germany (TAVI registry). The impact of gender differences on the clinical outcome after TAVI was examined in small studies with conflicting results. Consecutive patients (n = 1,432) undergoing TAVI in the period between January 2009 and June 2010 in Germany were evaluated. Differences in all-cause mortality were examined with Kaplan-Meier estimates and proportional hazards models. Women comprised 57.8 % of the cohort. The Edwards Sapien valve (18.5 %) and CoreValve (81.5 %) were used through the transfemoral (87.7 %), subclavian (3.0 %), transapical (8.6 %), or transaortic approach (0.7 %). At baseline, women had higher aortic gradients and were older. Men had more comorbidities: prior myocardial infarction, prior revascularization, prior coronary artery bypass surgery, peripheral arterial vascular disease and chronic obstructive pulmonary disease. Women had more periprocedural vascular complications in comparison to men (25.2 vs. 17.2 %, p < 0.001). There was no significant difference in mortality at 30-day follow-up (7.6 % for women vs. 8.6 % for men, p = 0.55). The adjusted HR for 1-year all-cause mortality favored women, HR 0.75 (95 % CI 0.57-0.98, p = 0.0346) with a mortality rate of 17.3 vs. 23.6 % for men. Female gender is associated with better 1-year survival after TAVI. These results suggest that TAVI could be the best treatment modality for elderly women with symptomatic severe aortic stenosis.

Frailty Found Vital to TAVR Prognosis

Frailty was associated with a threefold increase in mortality risk 1 year after transcatheter aortic valve replacement in an elderly cohort, according to a single-center study published online in JACC: Cardiovascular Interventions. However, the researchers also found that there was no significant association between frailty status and the majority of post-TAVR outcomes, suggesting that the current standard for patient selection is adequate. “We hope that the result will convince physicians to measure frailty,” Dr. Philip Green, the study's lead author and a fellow in cardiovascular medicine at Columbia University Medical Center, New York, where the study was conducted, said in an interview. “Formally assessed frailty can be extremely useful for prognostic information.” Risk prediction for older adults undergoing cardiac surgery is somewhat tricky, said Dr. Green, because some of the well-established measurement tools are based on studies that did not include many very old or high-risk adults. For an objective frailty score, Dr. Green said he and colleagues measured gait speed, grip strength, serum albumin, and activities of daily living to derive a frailty score in 159 very-high-risk patients with severe aortic stenosis who underwent TAVR at the Valve Center at Columbia University Medical Center/New York–Presbyterian Hospital. Patients' mean age was 86 years, and half were men. Half of the patients had at least three comorbidities, although the frailty score was not associated with the number of comorbidities. Overall, 76 patients had a frailty score higher than 5, and 83 had a score of 5 or less (considered not frail) (JACC Cardiovasc. Interv. 2012;5:974-81). Eight patients died during the first 30 days; however, frailty status was not associated with periprocedural vascular complications, stroke, or procedural mortality. Meanwhile, 1-year follow-up showed that patients with a frailty score of more than 5 had a threefold increase in mortality after the procedure, compared with the nonfrail group (17 frail vs. 7 nonfrail; hazard ratio, 1.15). “But it's really important to distinguish between frailty and futility,” said Dr. Green. “Even the frail group had an 80% survival rate, and that suggests that even the most frail can tolerate and live for a long time after TAVR.” “Understand the functional status of your patients,” advised Dr. Green. “Understand their abilities to perform activities and their nutritional status. It can shed light on patients who are thriving despite their heart disease and other comorbidities compared to those who are really limited [by] their diseases.” Dr. Green said that he had no relevant conflict of interest. Editor's NoteCertainly, assessment of frailty is a good idea for all of our patients, not just for those contemplating TAVR. And there's no question that frailty has a substantial negative impact on prognosis. But in this study, even the frail patients did pretty well.A hazard ratio of 1.15 is not a huge incremental risk, and more than 80% of these frail patients survived for a year – which they probably would not have, considering critical aortic stenosis, without the procedure. Now, whether the increase in quality and quantity of life is worth the burdens and risks of treatment, and the substantial economic costs, is a question that must be addressed among patients, clinicians, and family for each individual. But this procedure is a great addition to our armamentarium.–Karl Steinberg, MD, CMD,Editor in Chief Certainly, assessment of frailty is a good idea for all of our patients, not just for those contemplating TAVR. And there's no question that frailty has a substantial negative impact on prognosis. But in this study, even the frail patients did pretty well. A hazard ratio of 1.15 is not a huge incremental risk, and more than 80% of these frail patients survived for a year – which they probably would not have, considering critical aortic stenosis, without the procedure. Now, whether the increase in quality and quantity of life is worth the burdens and risks of treatment, and the substantial economic costs, is a question that must be addressed among patients, clinicians, and family for each individual. But this procedure is a great addition to our armamentarium. –Karl Steinberg, MD, CMD, Editor in Chief

Comparison of Adverse Cardiovascular Events and Bleeding Complications of Loading Dose of Clopidogrel 300 mg Versus 600 mg in Stable Patients Undergoing Elective Percutaneous Intervention (from the CADICE Study)

In large clinical trials enrolling patients with acute coronary syndromes, a high loading dose of clopidogrel (600 mg) has been found to be more effective compared to a low loading dose (300 mg). However, the applicability of these data to stable patients who undergo elective percutaneous coronary intervention is still unclear. A total of 400 patients who underwent elective PCI were prospectively randomized to receive either 600 mg (n = 200) or 300 mg (n = 200) of clopidogrel, followed by a daily maintenance dose of 75 mg. The primary end point was the presence of major adverse cardiovascular events (combined death, myocardial infarction, acute neurologic event, stent thrombosis, and need for percutaneous or surgical revascularization of the target vessel) during hospitalization and at 30 days. The secondary end point was periprocedural vascular complications, major bleeding, and cardiac enzyme elevation. There were no differences in the primary end point among the groups immediately after the procedure (3.5% of patients in the 300-mg group vs 4.5% of those in the 600-mg group, p = 0.799) or at 30 days (6% vs 5%, respectively, p = 0.826). The rates of periprocedural vascular complications (2.5% vs 3%, respectively, p = 1.00), bleeding complications (9% vs 8.5%, respectively, p = 1.00), and cardiac enzyme elevation (11% vs 15.5%, respectively, p = 0.317) were similar between the 2 groups. In conclusion, adverse cardiovascular events and bleeding complications during the initial hospitalization and at 30-day follow-up were similar when a 600-mg loading dose of clopidogrel was used compared to the conventional dose of 300 mg.

Troponin T elevation after successful directional atherectomy.

The incidence and correlates of postinterventional cardiac troponin T (cTnT) elevation have not been evaluated in patients with successful directional atherectomy (DCA). Total creatine kinase (CK) activity, CK-MB mass concentrations and cTnT levels were measured in 36 patients before, and serially 4, 24, 48 and 72 hours after successful DCA. Patients were followed for death, Q-wave infarction, need for emergency bypass surgery, periprocedural vascular complications (transient in-lab vessel closure, side branch compromise, large dissection), and non-Q-wave infarction on ECG. Patients were followed for clinical outcomes and angiographic restenosis for 6 months. Vascular correlates were studied by coronary angiography and intravascular ultrasound before, immediately after and 4 hours after elective and successful DCA. 25 patients (69.4%) had elevated levels of cTnT, whereas CK-MB mass > or = 6 ng/ml and mild elevations of total CK activity were present in only 36.1 and 5.6%, respectively. Elevated cTnT was related to vascular complications in 44% of cases. Inapparent microembolization of platelets or plaque debris was considered responsible for most of the remaining micronecroses. During 6 month follow-up rates of clinical restenosis (44 vs 9%, p = 0.059) tended to be higher in patients with as compared to patients without cTnT release after DCA. Successful DCA is associated with postprocedural elevations of cTnT which relate to minor vascular complications and presumably microembolization of platelets or plaque debris. The superior diagnostic performance of cTnT compared to CK-MB mass may relate to more sensitive identification of microinfarction. Further studies are mandatory to confirm the association between elevation of cTnT and risk of restenosis and TVR.