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.

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.

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.

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.

Long-term outcome of conservatively treated patients with borderline coronary lesions--role of the fractional flow reserve measurement.

BACKGROUND: Coronary fractional flow reserve (FFR) has been recommended as one of the functional methods which can be used to establish indications for revascularisation in patients with borderline coronary lesions. AIM: To assess long-term outcome of patients with borderline coronary lesions in whom the decision to implement conservative treatment was based on the results of FFR. METHODS: The study group consisted of 41 patients (13 females, mean age 61+/-9 years) who had CCS class II angina, an isolated borderline (40-70%) coronary lesion and FFR >0.75. All patients received 40 mg of simvastatin, angiotensin converting enzyme inhibitor and aspirin. The follow-up duration ranged from 7 to 32 months (mean 15.2+/-7.1, median 14.5 months). The analysed end-points included cardiac death, myocardial infarction (MI) (with or without ST segment elevation) and revascularisation of the target coronary artery. RESULTS: The mean FFR value in the whole study group was 0.91+/-0.05. Three (7%) patients had complications during follow-up: one patient developed MI, and two had coronary artery stenosis progression, requiring angioplasty. These patients had similar clinical and angiographic characteristics as well as FFR values as patients without complications. Among patients with uneventful outcome, in 33 (87%) anginal symptoms improved whereas in the remaining 5 (13%) patients CCS class did not change. Patients with angina alleviation were older and had higher FFR values than patients without improvement (63+/-8 vs 48+/-6 years, p=0.0005; and 0.92+/-0.05 vs 0.86+/-0.08, p=0.04, respectively). CONCLUSIONS: In patients with borderline coronary lesions and stable angina, angioplasty can be delayed on the basis of the FFR results. This approach is safe and is associated with an asymptomatic long-term follow-up in more than 90% of patients.

Borderline coronary lesions may lead to serious coronary events--long-term outcome in 65 conservatively treated patients.

BACKGROUND: The choice of optimal therapy in a patient with borderline coronary lesion is difficult. The long-term outcome of conservatively treated patients has not yet been well defined. AIM: To analyse long-term outcome in patients with a borderline lesion in a single coronary artery who were selected for conservative treatment. METHODS: The study group consisted of 65 patients (mean age 59.4+/-7.4 years, 48 males) with (1) stable angina (CCS class I/II), (2) isolated single borderline coronary lesion (40-70% stenosis demonstrated by quantitative coronary angiography) and (3) no demonstrable ischaemia during non-invasive tests. Patients with heart failure, left ventricular ejection fraction <50% or acute coronary syndrome within 6 months preceding the study were not included. All patients were prescribed statins, angiotensin converting enzyme inhibitors and aspirin. Follow-up end-points included cardiac death, new myocardial infarction (MI) with or without ST segment elevation and revascularisation of the target coronary artery. RESULTS: The follow-up duration was 18.4+/-8.5 months (range 12-33, median 18 months). Forty nine (75%) patients remained free from angina during daily activity. Coronary events occurred in 16 (25%) patients, including three (5%) serious complications -- sudden death, new MI with ST elevation and new MI without ST elevation. The remaining 13 (20%) patients underwent percutaneous revascularisation of the target coronary artery. Coronary angiography was repeated in 16 (25%) patients. When the patients were divided into two groups according to the follow-up results (with or without coronary event), no differences in the clinical characteristics, lesion localisation and length or degree of stenosis were noted. CONCLUSIONS: (1) Conservatively treated patients with stable angina and borderline coronary stenosis have a high rate of coronary events, especially revascularisation, during a long-term follow-up. (2) Clinical parameters and quantitative coronary angiography do not identify those patients with borderline coronary lesions who are at increased risk of future coronary events.

Measurement of coronary fractional flow reserve. Standard doses of intracoronary adenosine are insufficient to induce maximal hyperaemia.

BACKGROUND: Induction of maximal hyperaemia is a prerequisite for a reliable estimation of fractional flow reserve (FFR) in a moderate coronary artery stenosis. Intracoronary adenosine is the most frequently used agent to achieve maximal hyperaemia. However, an insufficient dose of adenosine may induce only partial hyperaemia, thus artificially increasing the FFR values. AIM: To assess the tolerability and effects on FFR value of increased doses of adenosine. METHODS: FFR was measured in 36 patients with 53 moderate coronary lesions. In order to induce maximal hyperaemia and assess FFR in the targeted coronary artery, intracoronary adenosine in a dose of 30 micro g was administered twice (FFR30). Next, 60 micro g of adenosine was tested twice (FFR60). In addition, in some patients with left coronary artery stenosis, 90 micro g of adenosine was also injected (FFR90). RESULTS: No significant side effects were noted except a transient, self-terminating episode of a second degree atrio-ventricular block in one patient. The mean value of FFR30 was significantly higher than FFR60 (0.854+/-0.152 vs 0.836+/-0.162, p<0.001), and the mean difference between these two measurements was 0.018+/-0.036. In 29 (54.7%) evaluated lesions, FFR30 values were higher than FFR60; in 12 (22.6%) measurements the difference exceeded 0.02, and in 8 (15%) cases - 0.05. The use of 90 micro g of adenosine did not further decrease FFR in any of the cases. CONCLUSIONS: An increase of the adenosine dose from 30 micro g to 60 micro g was well tolerated and caused further decrease in the FFR values which may be of clinical importance in some patients. The use of 90 micro g of adenosine did not further decrease FFR.

Measurement of fractional flow reserve in patients with multi-vessel coronary artery disease and borderline lesions prevents unnecessary revascularisation procedures.

BACKGROUND: Patients with multi-vessel coronary artery disease (CAD) are selected for percutaneous coronary interventions (PCI) or surgical revascularisation. The appropriateness of "ad hoc" PCI of borderline lesions (<70% of lumen diameter) in patients with a multi-vessel CAD has not been proven. However, delayed PCI of another lesion and gaining additional information from non-invasive tests is not a widely accepted strategy. When left anterior descending (LAD) coronary artery is one of the affected vessels, selection for surgical revascularisation is most likely. AIM: To assess long-term outcome in patients with multi-vessel CAD and borderline lesions, including LAD, in whom fractional flow reserve (FFR) in all affected vessels was measured and used for selection for PCI or conservative treatment. METHODS: The study group consisted of 16 patients with stable angina (11 males, mean age 60+/-9 years) with 34 lesions localised in the main epicardial coronary arteries [LAD / left main (LM) / right coronary artery (RCA) / intermediate branch (IB) / circumflex artery (Cx) - 15/1/5/5/8] of which at least two were borderline stenoses. Each lesion underwent FFR measurement. "Ad hoc" PCI was performed when FFR was <0.75, and conservative therapy was instituted when FFR was >0.75. RESULTS: Of 34 lesions, in 8 (23%) the FFR value was <0.75 and these lesions were treated with PCI (LAD/IB/Cx - 3/2/3). In the remaining 26 (77%) lesions, FFR was >0.75 and conservative therapy was instituted. During the mean follow-up of 15+/-6 months (range 6-28 months, median 15 months) in 8 of 9 conservatively treated patients no aggravation of anginal symptoms nor other coronary events were observed. One patient developed acute myocardial infarction due to thrombus occluding a borderline LAD lesion. Of 8 lesions treated with PCI (baseline FFR = 0.63+/-0.10 vs post-PCI FFR = 0.92+/-0.08, p=0.0002), in one case an in-stent restenosis in LAD occurred 9 months after PCI. Of a total of 26 lesions which were conservatively treated (mean FFR 0.91+/-0.05), in 2 (7.7%) the progression of CAD was noted. CONCLUSIONS: In patients with multi-vessel CAD and borderline lesions, FFR measurement identifies those, who can be treated conservatively with a good long-term outcome, and prevents unnecessary PCI.