Multicenter registry of Impella-assisted high-risk percutaneous coronary interventions and cardiogenic shock in Poland (IMPELLA-PL).

BACKGROUND: Impella is a percutaneous mechanical circulatory support device for treatment of cardiogenic shock (CS) and high-risk percutaneous coronary interventions (HR-PCIs). IMPELLA-PL is a national retrospective registry of Impella-treated CS and HR-PCI patients in 20 Polish interventional cardiological centers, conducted from January 2014 until December 2021. AIMS: We aimed to determine the efficacy and safety of Impella using real-world data from IMPELLA-PL and compare these with other registries. METHODS: IMPELLA-PL data were analyzed to determine primary endpoints: in-hospital mortality and rates of mortality and major adverse cardiovascular and cerebrovascular events (MACCE) at 12 months post-discharge. RESULTS: Of 308 patients, 18% had CS and 82% underwent HR-PCI. In-hospital mortality rates were 76.4% and 8.3% in the CS and HR-PCI groups, respectively. The 12-month mortality rates were 80.0% and 18.2%, and post-discharge MACCE rates were 9.1% and 22.5%, respectively. Any access site bleeding occurred in 30.9% of CS patients and 14.6% of HR-PCI patients, limb ischemia in 12.7% and 2.4%, and hemolysis in 10.9% and 1.6%, respectively. CONCLUSIONS: Impella is safe and effective during HR-PCIs, in accordance with previous registry analyses. The risk profile and mortality in CS patients were higher than in other registries, and the potential benefits of Impella in CS require investigation.

Transcatheter aortic valve­in­valve implantation for failed surgical bioprostheses: results from the Polish Transcatheter Aortic Valve-in-Valve Implantation (ViV­TAVI) Registry

INTRODUCTION: Transcatheter aortic valve­in ­valve implantation (ViV­TAVI) has emerged as an alternative to redo surgery in patients with failed surgical aortic bioprosthesis. OBJECTIVES: We evaluated the safety and efficacy of ViV­TAVI in Polish patients after surgical aortic valve replacement. PATIENTS AND METHODS: This was a nationwide multicenter registry of ViV­TAVI procedures. Data were collected using an online form, and the clinical follow ­up lasted 1 year. RESULTS: From 2008 to 2020, 130 ViV­TAVI procedures were performed (1.9% of all transcatheter aortic valve implantation [TAVI] cases). A considerable increase in ViV­TAVI procedures since 2018 has been observed (n = 59, 45% of ViV­TAVI cases). Hancock II, Freestyle, and homograft were the most frequently treated bioprostheses. The self ­expanding supra ­annular Corevalve / Evolut valve was used in 76% of cases. In 21% of cases, the mean postprocedural pressure gradient (PG) exceeded 20 mm Hg. All­cause mortal­ity at 1 year was 10.8%. Aortic valve stenosis was associated with a higher mean PG than aortic valve regurgitation or mixed disease (P = 0.004). Supra ­annular transcatheter aortic valves were associated with lower mean PGs than intra ­annular valves (P = 0.004). Second ­generation devices were associated with shorter procedure time (120 min vs 135 min, P = 0.04), less frequent need for additional TAVI (2% vs 10%, P = 0.04), and lower 1­year cardiovascular mortality (95% vs 82.8%, P = 0.03) than first­generation valves. CONCLUSIONS: Transcatheter treatment of failed bioprostheses is increasingly common, with the best hemodynamic effect shown for supra ­annular valves. The introduction of second­generation valves has improved procedural and clinical outcomes.

Utility of the SYNTAX Score in the risk stratification of patients undergoing rotational atherectomy.

INTRODUCTION: The SYNTAX Score (SS) evaluates the angiographic complexity of coronary artery disease to assess the cardiovascular risk after coronary revascularization. The aim of the study was to evaluate whether SS results are associated with in-hospital and 1-year outcomes of patients undergoing percutaneous coronary intervention (PCI) requiring rotational atherectomy (RA). MATERIAL AND METHODS: We analyzed data of 207 consecutive patients who underwent PCI with RA. Patients were divided into two groups: those with high SS (> 33 points) and those with low/intermediate SS (0-33 points). RESULTS: In 21 (10%) patients SS was high and 186 (90%) patients had low/intermediate SS. Patients with high SS were older (76 vs. 71 years, p = 0.008) and more frequently diagnosed with chronic kidney disease (38% vs. 18%, p = 0.03) and heart failure (71% vs. 30%, p = 0.0001). In patients with high SS the RA procedure was longer (p = 0.004), required more contrast (p = 0.005) and higher radiation doses (p = 0.04), and contrast-induced nephropathy was more frequent (14% vs. 2%, p = 0.001). CONCLUSIONS: In our RA patients there was no significant difference between the frequency of in-hospital and 1-year adverse cardiovascular events depending on the SS result. High SS correlates only with parameters describing the extensity and technical complexity of the procedure. However, the unavailability of other risk assessment tools in this population raises the need to create a new more specific risk score for patients requiring RA.

The use of rotational atherectomy in high-risk patients: results from a high-volume centre.

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.

Novel predictors of outcome after coronary angioplasty with rotational atherectomy. Not only low ejection fraction and clinical parameters matter.

INTRODUCTION: Most established risk factors after rotational atherectomy (RA) of heavily fibro-calcified lesions are associated with patients' general risk and clinical related factors and are not specific for either coronary and culprit lesion anatomy or the RA procedure. AIM: To assess novel predictors of poor outcome after percutaneous coronary intervention using RA in an all-comers population. MATERIAL AND METHODS: A total of 207 consecutive patients after RA were included in a single-center observational study. Primary endpoints were 1-year mortality and 1-year major adverse cardiac events (MACE). Secondary endpoints were angiographic and procedural success and in-hospital complications. RESULTS: Procedural complications occurred in 19 (8%) patients. In-hospital mortality was 1%, peri-procedural myocardial infarction (MI) was 9%, and acute stroke occurred in one patient. The 1-year MACE rate was 20% with all-cause mortality 10%, MI 10% and stroke 1%. Multivariable analysis revealed heart failure with left ventricle ejection fraction (LVEF) ≤ 35% (p = 0.02) and uncrossable lesion, as compared to undilatable lesion (p = 0.01), as independent predictors of 1-year mortality and residual SYNTAX score ≤ 8 as an independent predictor of favorable outcome (p = 0.04). Heart failure with LVEF ≤ 35% (p < 0.01) and uncrossable lesion (p = 0.04) were independent predictors of 1-year MACE. CONCLUSIONS: The presence of a novel factor, uncrossable lesion, as compared to undilatable lesion, is associated with poor outcome, and low residual SYNTAX score ≤ 8 is associated with favorable outcome in 1-year follow-up after the RA procedure and can help in risk stratification of patients undergoing complex coronary intervention with RA.

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.

Acute coronary syndrome - Still a valid contraindication to perform rotational atherectomy? Early and one-year outcomes.

BACKGROUND: Rotational atherectomy (RA) is an acknowledged method of percutaneous treatment of highly calcified or fibrotic coronary lesions. However, using the rotablator system in patients presenting with acute coronary syndromes (ACS) remains controversial and is considered as a relative contraindication. The aim of our study was to assess in-hospital and 1-year outcomes in patients undergoing RA presenting with ACS, in comparison to elective RA procedures. METHODS: This single-center observational study included all consecutive patients who underwent RA and PCI in our institution from April 2008 to October 2015. All patients were subsequently divided into two groups based on clinical presentation: stable angina group (SA) and ACS group. Primary endpoints were in-hospital and 1-year all-cause mortality and 1-year major adverse cardiac events (MACE). Secondary endpoints were procedural success and in-hospital complications. RESULTS: The study included 207 patients, 164 (79%) in SA group and 43 (21%) in ACS group. In-hospital mortality was higher in patients with ACS (4.7% vs. 0%, p=0.01). Procedural success was similar in both groups, 93% in ACS groups vs. 92.7% in SA group, p=0.94. There were no significant differences in the rate of periprocedural complications (4.7% vs. 10.4%, p=0.25), however postprocedural complications were more frequent in ACS group. At 1-year follow-up MACE rate and mortality were numerically higher, however statistically not significant (25.6% vs. 16.5%, p=0.17 and 16.3% vs. 7.9%, p=0.10; respectively). CONCLUSIONS: Despite higher mortality and complication rate in ACS group observed in postprocedural period, we found no significant difference in 1-year outcomes in comparison to elective patients. Procedural success of RA in ACS patients is similar to elective patients with SA and this procedure should be considered in case of urgent indications, if no other options of treatment exist.

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.

Percutaneous reduction of mitral valve regurgitation using the MitraClip system - immediate and 90-day follow-up of 3 cases.

Treatment of hemodynamically significant valvular heart diseases has been the domain of cardiac surgery for decades. However, a promising novel method is the MitraClip system, involving percutaneous connection of insufficient valve leaflets with special cobalt-chrome clips. Our study presents clinical characteristics, course of treatment with the MitraClip system, and immediate and 90-day clinical and echocardiographic follow-up of the first 3 patients treated in our institution. Subsequently, based on data from the literature and our own experience, the current position around the world, and the target group of patients who are most likely to benefit from treatment using the MitraClip system, are discussed.