Piotr Kübler

Can TAVI patients receive aspirin monotherapy as patients after surgical aortic bioprosthesis implantation? Data from the Polish Registry — POL-TAVI

BACKGROUND This observational analysis investigated in-hospital safety and efficacy of periprocedural antithrombotic/antiplatelet therapy used in TAVI patients included into the Polish Nationwide Cardiac Surgical and Cardiology Registry of Transcatheter Aortic Valve Implantation (POL-TAVI). METHODS AND RESULTS All patients who underwent TAVI in the participating centers between 2013 and 2014 were included. The primary endpoints were: severe bleeding, vascular complications, thromboembolic events, myocardial infarction, 30-days mortality, defined according to Valve Academic Research Consortium scale 2. A total of 827 patients were included; 35-93years old (79.31±7.53); 457 (55.29%) women. Endpoints noted: severe bleeding - 130 (15.72%) pts, vascular complications - 135 (16.32%) pts, thromboembolic events - 29 (3.5%) pts, myocardial infarction - 24 (2.90%) pts, deaths - 58 (7.01%) pts. Aspirin premedication, resulted in the least number of vascular complications (OR 0.56 95%CI [0.345-0.938]; p=0.027). Aspirin after TAVI reduced the risk of vascular complications (OR 0.089 95%CI [0.0217-0.372]; p=0.001) and bleeding (OR 0.138 95%CI [0.043-0.447]; p=0.001) with no adverse impact on efficacy endpoints. Beneficial safety profile of postprocedural aspirin monotherapy remained significant in comparison to all other types of prophylaxis also in propensity score analysis: OR 0.068 95%CI [0.009-0.529]; p=0.01 for vascular complications, OR 0.176 95%CI [0.049-0.627]; p=0.007 for bleeding. NNT for vascular complications and bleeding with postprocedural aspirin prophylaxis was 5.5 and 6.42, respectively. CONCLUSION Aspirin after TAVI appears to be beneficial than currently recommended dual antiplatelet therapy; therefore, it might be considered as TAVI antithrombotic prophylaxis.

Radial artery occlusion after percutaneous coronary interventions - an underestimated issue.

The femoral approach is the most common arterial access for percutaneous coronary artery interventions. Despite the convenience and simplicity of this approach, it is burdened with a high risk of arterial puncture bleeding, which worsens the prognosis of the patient. An alternative approach through the radial artery has been gaining more and more popularity in recent years. This is due to a significant reduction of local bleeding complications as compared with the femoral artery approach. The use of the radial approach in patients with ST-segment elevation myocardial infarction improves outcome, reducing the risk of death, subsequent myocardial infarction and stroke, and is the preferred approach according to the latest ESC guidelines. In addition to improving safety, it is beneficial for improving patient comfort, with a shorter recovery after the procedure, shorter hospitalization and lower medical costs. One of the major complications of procedures performed through the radial approach is radial artery occlusion (RAO). Although it usually has an asymptomatic course, RAO eliminates the ability to use the radial artery as an access in the future. A number of factors that contribute to the occurrence of RAO have been identified, such as the size of the sheath and the catheter, diameter ratio of the sheath to the diameter of the radial artery, insufficient anticoagulation and, above all, the way of obtaining hemostasis at the puncture site: the duration of artery compression after sheath removal and the preservation of artery patency during compression (so-called patent hemostasis). This paper presents the current state of the art about the factors that contribute to the occurrence of RAO and methods for preventing this complication.

The use of drug-eluting stents in acute myocardial infarction – is the battle coming to an end? From despair to acceptance

The large-scale use of drug-eluting stents (DES) in elective percutaneous coronary interventions resulted in a significant reduction of restenosis and the need for repeat revascularization, compared to bare-metal stents (BMS) and balloon angioplasty. The position of DES used during primary percutaneous coronary intervention was not so well established. Based on the trials including the general population of patients, an increased risk of stent thrombosis was indicated, particularly late after implantation, which may be associated with increased mortality. A number of randomized clinical trials have compared first generation DES with BMS in acute ST-segment elevation myocardial infarction (STEMI). In most of them increased mortality after DES implantation was not confirmed, with demonstrated reduction of repeat revascularizations. However, long-term follow-up of these studies and the results from non-randomized “real world” registries are equivocal. A new generation of DES has been present on the market for several years. They have modern designs, are covered with more neutral polymers and release new drugs. The new generation DES have a better safety and efficacy profile, including a population of patients with acute STEMI, than the first generation stents. This paper is a review of randomized controlled trials, meta-analyses and registries, comparing DES with BMS in patients with acute STEMI. Attention was drawn to the current position and the role of new generation DES, which may prove to be a safe and effective choice in this population of patients.

Optimal stent treatment of cardiogenic shock complicating acute myocardial infarction: bare-metal or drug-eluting stent?

Implantation of bare-metal stents (BMS) in the early 1990s was a milestone in the development of interventional cardiology.1 Stents provided benefits compared with balloon angioplasty alone by reducing the risk of acute vessel occlusion and recurrent ischaemia, and by optimising acute lumen gain and preventing early vessel recoil. A decade later the implementation of drug-eluting stents (DES) has further improved clinical outcomes mainly by substantially reducing restenosis, the Achilles′ heel of BMS. However, because of impaired vascular healing, there was a higher risk of late and very late stent thrombosis (ST) associated with the first-generation DES when compared with BMS. ST is a potentially catastrophic event so the widespread perception that BMS may be safer than DES was initiated and, as a consequence, the frequency of DES implantations substantially decreased around the world. To overcome the safety concerns of the first-generation DES, newer devices have been developed with new stent platforms and designs, with more biocompatible polymers or without polymers and with new antiproliferative agents. The outcomes after implantation of the second-generation DES have been much better in comparison to BMS and the first-generation DES in terms of efficacy and safety.2 The results achieved with the new-generation DES are so convincing that in a recent review published in the European Heart Journal, the authors conclude: “We suggest that BMS should be honourably retired and added to the history books (…)”.3 They also cite a …

Patients with acute myocardial infarction and severe target lesion calcifications undergoing percutaneous coronary intervention have poor long-term prognosis

BACKGROUND To assess the influence of severe target lesion calcification (TLC) on the outcomes of patients undergoing percutaneous coronary interventions (PCI) due to acute myocardial infarction (AMI). AIM Contemporary data concerning coronary artery calcifications (CAC) are based on pooled analyses from randomised trials with short follow-up. We still lack the knowledge on how CAC in target lesions affect long-term prognosis of patients with AMI in everyday practice. METHODS We evaluated clinical and laboratory data of 206 consecutive patients who underwent coronary angiography and PCI due to AMI. Primary endpoints were all-cause death and recurrent hospitalisations due to acute coronary syndrome (ACS). RESULTS Severe TLC lesions were present in 17% of patients. These patients were older (71 vs. 65 years, p = 0.02) and more often diagnosed with non-ST segment elevation myocardial infarction (77% vs. 58%, p = 0.03). Patients with severe TLC had lower rates of PCI success (80% vs. 97%, p < 0.0001) and less often achieved full revascularisation during index procedure (14% vs. 41%, p = 0.003). During 30 months follow-up patients with severe TLC more often suffered from another ACS (37% vs. 13%, p = 0.0005) and had higher all-cause mortality (31% vs. 16%, p = 0.04). Multivariate Cox regression model showed severe TLC to be an independent predictor of another ACS (HR 2.8; 95% CI 1.4-5.6; p = 0.004). CONCLUSIONS Severe TLC are not uncommon in patients with ACS. The presence of severe TLC is a prognostic factor of another ACS in AMI patients undergoing PCI.

Safety and efficacy assessment of carotid artery stenting in a high-risk population in a single-centre registry.

Introduction Ischaemic stroke is the primary cause of long-term disability and the third most common cause of death. Internal carotid artery stenosis is an important risk factor for stroke and transient ischaemic attack (TIA). European Society of Cardiology (ESC) and American Heart Association (AHA) guidelines allow carotid artery stenting (CAS) as an alternative to endarterectomy in centres with low rates of death or stroke. Aim To assess the safety and efficacy of CAS in a single-centre observation. Material and methods We performed a retrospective analysis of all patients treated with CAS between March 2008 and July 2012. Clinical data and outcomes in both asymptomatic and symptomatic patients were analysed. Results A total of 214 consecutive patients were included in the registry. Symptomatic patients accounted for 57% of the study group and were more likely to have a history of stroke and/or TIA that occurred more than 6 months before the procedure (50% vs. 8%, p < 0.001). Asymptomatic patients were more likely to have a history of coronary artery disease (88% vs. 61%, p < 0.001), and the rates of previous acute coronary syndrome and revascularisation were also higher in this group (58% vs. 41% and 71% vs. 52%, respectively, both p < 0.05). The symptomatic group had higher incidence of stroke in periprocedural and 30-day observation (4% vs. 0%, p < 0.05). There was no difference in incidence of adverse events in long-term observation. Conclusions Carotid artery stenting is a safe and efficacious procedure. Every centre performing CAS should monitor the rate of periprocedural complications.

The use of rotational atherectomy in high risk patients: high volume centre results

BACKGROUND Rotational atherectomy (RA) is indicated for fibrocalcified lesions when traditional percutaneous coronary intervention (PCI) could not be successfully performed. In some of the high-risk patients the RA procedure is the last resort for successful revascularisation. Such patients are, among others, those in whom coronary artery bypass grafting (CABG) is not feasible. AIM The aim of the study was to assess in-hospital and one-year outcomes of PCI with RA in high-risk patients without other revascularisation options (RA-only group), in comparison to lower-risk patients undergoing RA. METHODS We evaluated data of 207 consecutive patients who underwent PCI with RA. Primary endpoints were one-year all-cause mortality and one-year major adverse cardiac events (MACEs). Secondary endpoints were in-hospital outcomes. RESULTS During the study 35% of patients fulfilled the inclusion criteria to the high-risk group. Those patients had significantly lower left ventricular ejection fraction, more often prior CABG, higher admission glucose level, and higher EuroSCORE II and Syntax Score. Procedural success was similar in both groups (85% in RA-only group vs. 91% in remaining patients, p = 0.18). In-hospital outcomes were similar, except more frequent no/slow-flow phenomenon in the RA-only group. The MACE and mortality rates in one-year follow-up were not statistically different in both groups (19% vs. 18%, p = 0.82 and 11% vs. 9%, p = 0.64, respectively). CONCLUSIONS Despite the high-risk characteristics of the study subgroup, no significant differences between in-hospital and one-year outcomes were found in comparison to lower-risk RA patients. Complex PCI with RA in patients without other revascularisation options should be taken into consideration.

Transcatheter aortic valve-in-valve implantation in failed stentless bioprostheses

OBJECTIVE To compare the safety and efficacy of transcathether aortic valve-in-valve implantation (ViV-TAVI) in degenerated stentless bioprostheses with failed stented valves and degenerated native aortic valves. INTRODUCTION Little is known about ViV-TAVI in degenerated stentless valves. METHODS Out of 45 ViV-TAVI procedures reported in the POL-TAVI registry, 20 failed stentless valves were compared with 25 stented prostheses and propensity-matched with 45 native TAVI cases. The mean follow-up was 633 (95% confidence interval [CI], 471-795) days and Valve Academic Research Consortium-2 (VARC-2) definitions were applied. RESULTS Patients with degenerated stentless valves were younger (65.6, CI 58-73.1 years vs 75.6, CI 72.2-78 [stented] vs 80.1, CI 78.7-81.6 y. [native], P < 0.001). Implantation was required later after surgery (11.5, CI 8-14.9 years) in the stentless cohort as compared with the stented one (6.2, CI 4.7-7.6 years, P = 0.006). ViV-TAVI in the stentless group was also associated with larger amount of contrast (211, CI 157-266 mL vs 135, CI 104-167 mL [stented] vs 132 (119-145) mL [native], P = 0.022). Using VARC-2 composite endpoints, ViV-TAVI in stentless prostheses was characterized by a lower device success (50% vs 76% in stented vs 88.9% in native TAVI, P < 0.001), but comparable early safety up to 30 days (73.7% vs 84% vs 81.8%, respectively, log-rank P = 0.667) and long-term clinical efficacy beyond 30 days (72.2% vs 72% vs 73.8%, respectively, log-rank P = 0.963). CONCLUSIONS Despite technical challenges and a lower device success, ViV-TAVI in stentless aortic bioprostheses achieves similar safety, efficacy, and functional improvement as in stented or degenerated native valves.

In patients undergoing percutaneous coronary intervention with rotational atherectomy radial access is safer and as efficient as femoral access

INTRODUCTION Transfemoral approach (TFA) may be preferred access site in order to facilitate complex percutaneous procedures such as rotational atherectomy (RA). Notwithstanding, there is a growing evidence that transradial approach (TRA) is associated with lower access site complication rates and even lower mortality. The aim was to assess in-hospital and 1-year outcomes in patients undergoing RA using TRA, in comparison to TFA. METHODS A single center observational study included all consecutive patients, who underwent RA from 2010 to 2015. Primary endpoints were procedural success, in-hospital mortality and major adverse cardiovascular events (MACE). Secondary endpoints were 1-year all-cause mortality and MACE. RESULTS The study included 177 patients, 69% in TRA group and 31% in TFA group. Except for male sex and logistic Euroscore II there were no differences in common risk factors. There was no difference in procedural success (95% vs 87%, P = 0.07) with even a trend in favor of TRA. Performing RA via TRA lower amount of contrast volume (P = 0.009) was used and hospital stay after the procedure was shorter (P = 0.004). Periprocedural complication rates were similar, however patients with TFA had significantly higher rate of major access site bleedings (13% vs 1%, P = 0.001), with no differences in mortality and other adverse events both in-hospital and during 1-year observation. CONCLUSIONS Even though RA is a demanding technique, when performed via TRA allows to maintain the same procedural success and long-term results in comparison to TFA, reduces in-hospital major access site bleedings, lowers the amount of contrast media and shortens hospital stay.

Safety and efficacy of self-apposing Stentys drug-eluting stent in left main coronary artery PCI: Multicentre LM-STENTYS registry

There is a paucity of data on left main (LM) percutaneous coronary intervention (PCI) therapy with dedicated DES platforms. The LM‐STENTYS is a multicenter registry aimed at evaluating clinical outcome after PCI of LM performed with a self‐apposing Stentys DES implantation.