Abstract
Purpose
The aim of this study was to report the safety of coronary rotational atherectomy (RA) in patients with severe aortic stenosis (AS). RA in the clinical setting seems challenging because coronary slow flow leads to hemodynamic instability.
Methods
Between October 2013 and May 2016, 1401 patients in the Optimized transCathEter vAlvular iNtervention (OCEAN) registry in Japan underwent transcatheter aortic valve implantation (TAVI). The primary study endpoint was procedural success, defined as residual stenosis <20% with final Thrombolysis in Myocardial Infarction flow 3.
Results
Twenty-five patients who underwent RA for heavily calcified lesions were included in the study. Low left ventricular ejection fraction (<35%) was present in 3 (12%) patients. The left main stem was involved in 7 (28%) patients. All patients were treated under intravascular image guidance. Intra-aortic balloon pumping was used in 4 (16%) patients. Planned balloon aortic valvuloplasty (BAV) was performed during the same session in 4 (16%) patients. Transvenous catecholamine was used in 10 (40%) patients. The majority of patients underwent drug-eluting stent implantation following RA (n = 23, 92%). Procedural success was achieved in all patients. Subsequent device success was achieved in 24 (96%) patients, with no 30-day mortality following TAVI.
Conclusions
RA in patients with severe AS seems extremely challenging; however, this procedure appears to be safe if mechanical and drug supports are appropriately utilized and the procedure is performed under intravascular image guidance.
1
Introduction
Significant coronary artery disease (CAD) is found in 40% to 75% of patients who undergo transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) . Percutaneous coronary intervention (PCI) prior to TAVI remains controversial ; however, optimal results should be obtained once the operators have determined that coronary recanalization is required. Notably, severely calcified coronary lesions are often seen in TAVI candidates because of their older age and/or multiple comorbidities. PCI for calcified lesions remains a challenge, primarily because of adverse plaque characteristics, which may result in device delivery failure, incomplete stent expansion, malapposition of stent struts, or subsequent restenosis . In the current drug-eluting stent (DES) era, rotational atherectomy (RA) is considered an important adjunct in plaque modification when operators are unable to cross lesions with any devices or obtain sufficient balloon expansion prior to stent implantation . Before TAVI became available, RA PCI was unlikely to be performed in patients with severe AS, because such patients underwent either surgical aortic valve replacement plus coronary artery bypass grafting or conservative treatment. Moreover, RA in patients with severe AS seems extremely challenging because potential complications include the slow-flow and no-flow phenomena caused by downstream fragments . Furthermore, limited data are available regarding this issue in case reports . Thus, in this study based on a real-world, large “Optimized transCathEter vAlvular iNtervention” (OCEAN) TAVI registry, we analyzed the safety of RA PCI in patients with severe AS.
2
Material and methods
Briefly, the OCEAN-TAVI is an ongoing multicenter prospective registry , currently involving 13 institutions in Japan. The University Hospital Medical Information Network (UMIN) registry number is UMIN000020423. A total of 1401 patients in the registry underwent TAVI between October 2013 and May 2016. Of the 185 patients who underwent PCI before or during the same session as TAVI, 25 patients treated with RA were analyzed in this study. The decision to perform RA was at the discretion of highly experienced operators in each center. All RA procedures were performed using the Rotablator® rotational atherectomy system (Boston Scientific Corp., Natick, MA, USA). Life-long low-dose aspirin was recommended for all patients in addition to a thienopyridine (75 mg of clopidogrel daily) after DES implantation. The arterial access site was chosen according to operator preference and anatomical availability. The RA procedure began with the smallest possible rotablation burr (1.25, 1.5, 1.75, or 2.0 mm). The decision to use intravascular image guidance was at the discretion of each operator. Temporary pacing was performed during RA if necessary. Immediately before intervention, intra-arterial or intravenous heparin was given to maintain an activated clotting time ≥ 250 s.
2.1
Definitions
Death was considered as cardiac in origin unless obvious noncardiac causes were identified. Target vessel revascularization (TVR) was defined as repeat revascularization by PCI or surgery on the target vessel. Myocardial infarction (MI) was defined as the presence of new pathological Q waves on the electrocardiogram, or an increase in the creatinine kinase-myocardial band >3 times the upper limit of normal . Periprocedural MI and stent thrombosis (ST) were defined according to the Academic Research Consortium definitions . Chronic kidney disease was defined as an estimated glomerular filtration rate < 60 mL/min/1.73 m 2 . Device success for subsequent TAVI was evaluated according to the Valve Academic Research Consortium-2 (VARC-2) criteria .
2.2
Study endpoints
The primary study endpoint was procedural success of RA PCI, defined as residual stenosis <20% with final Thrombolysis in Myocardial Infarction flow 3. The secondary study endpoints were as follows: periprocedural MI; coronary obstruction during TAVI; device success; and all-cause mortality, TVR, and ST up to 30 days following TAVI.
2.3
Statistical analysis
The values are presented as mean ± standard deviation or median for normally and non-normally distributed continuous variables, respectively, or as counts and percentages for categorical variables. All analyses were retrospective and carried out using IBM SPSS Statistics for Windows, Version 19.0 (IBM Corp., Armonk, NY, USA).
2
Material and methods
Briefly, the OCEAN-TAVI is an ongoing multicenter prospective registry , currently involving 13 institutions in Japan. The University Hospital Medical Information Network (UMIN) registry number is UMIN000020423. A total of 1401 patients in the registry underwent TAVI between October 2013 and May 2016. Of the 185 patients who underwent PCI before or during the same session as TAVI, 25 patients treated with RA were analyzed in this study. The decision to perform RA was at the discretion of highly experienced operators in each center. All RA procedures were performed using the Rotablator® rotational atherectomy system (Boston Scientific Corp., Natick, MA, USA). Life-long low-dose aspirin was recommended for all patients in addition to a thienopyridine (75 mg of clopidogrel daily) after DES implantation. The arterial access site was chosen according to operator preference and anatomical availability. The RA procedure began with the smallest possible rotablation burr (1.25, 1.5, 1.75, or 2.0 mm). The decision to use intravascular image guidance was at the discretion of each operator. Temporary pacing was performed during RA if necessary. Immediately before intervention, intra-arterial or intravenous heparin was given to maintain an activated clotting time ≥ 250 s.
2.1
Definitions
Death was considered as cardiac in origin unless obvious noncardiac causes were identified. Target vessel revascularization (TVR) was defined as repeat revascularization by PCI or surgery on the target vessel. Myocardial infarction (MI) was defined as the presence of new pathological Q waves on the electrocardiogram, or an increase in the creatinine kinase-myocardial band >3 times the upper limit of normal . Periprocedural MI and stent thrombosis (ST) were defined according to the Academic Research Consortium definitions . Chronic kidney disease was defined as an estimated glomerular filtration rate < 60 mL/min/1.73 m 2 . Device success for subsequent TAVI was evaluated according to the Valve Academic Research Consortium-2 (VARC-2) criteria .
2.2
Study endpoints
The primary study endpoint was procedural success of RA PCI, defined as residual stenosis <20% with final Thrombolysis in Myocardial Infarction flow 3. The secondary study endpoints were as follows: periprocedural MI; coronary obstruction during TAVI; device success; and all-cause mortality, TVR, and ST up to 30 days following TAVI.
2.3
Statistical analysis
The values are presented as mean ± standard deviation or median for normally and non-normally distributed continuous variables, respectively, or as counts and percentages for categorical variables. All analyses were retrospective and carried out using IBM SPSS Statistics for Windows, Version 19.0 (IBM Corp., Armonk, NY, USA).
3
Results
Patient characteristics are shown in Table 1 . Aortic valve area and mean aortic pressure gradient were 0.60 ± 0.14 cm 2 and 46.8 ± 13.5 mmHg, respectively. Low left ventricular ejection fraction (LVEF; <35%) was seen in 3 (12%) patients. Angiographic characteristics are shown in Table 2 . The left main stem was treated in 7 (28%) patients. Procedural characteristics are shown in Table 3 . Intra-aortic balloon pumping (IABP) was used electively in 4 (16%) patients. Planned BAV was performed during the same session in 4 (16%) patients, and TAVI was performed in 1 (4%) patient. The burr-to-artery ratio was 0.55 ± 0.07. All patients were treated under intravascular image guidance mainly using intravascular ultrasound (IVUS). The majority of the patients (23 patients, 92%) received DES implantation following RA. Intravenous catecholamine during RA PCI was used in 10 (40%) patients. TAVI details are shown in Table 4 .
| Patient n = 25 | |
|---|---|
| Age, years | 85.5 ± 5.2 |
| Male | 7 (28%) |
| Weight, kg | 47.6 ± 9.7 |
| Height, m | 1.47 ± 0.09 |
| BMI, kg/m 2 | 21.9 ± 3.4 |
| Hypertension | 17 (68%) |
| Diabetes mellitus | 9 (36%) |
| Insulin dependent diabetes mellitus | 1 (4%) |
| Dyslipidemia | 11 (44%) |
| Current smoker | 0 |
| CKD (eGFR <60 ml/min/1.73 m 2 ) | 17 (68%) |
| Peripheral artery disease | 4 (16%) |
| Prior MI | 2 (8%) |
| Prior PCI | 12 (48%) |
| Prior CABG | 1 (4%) |
| Prior PMI | 2 (8%) |
| Logistic EuroSCORE, % | 19.7 (3.2–89.7) |
| EuroSCORE II score, % | 6.5 (1.7–57.4) |
| STS score, % | 8.7 (3.1–64.2) |
| Echocardiographic data | |
| Aortic valve area, cm 2 | 0.60 ± 0.14 |
| Peak velocity, m/s | 4.4 ± 0.6 |
| Mean gradient, mmHg | 46.8 ± 13.5 |
| Peak gradient, mmHg | 79.3 ± 22.6 |
| LVEF, % | 57.1 ± 13.5 |
| LVEF <35% | 3 (12%) |
| AR grade 3/4 | 3 (12%) |
| MR grade 3/4 | 5 (20%) |
| Patient n = 25 | |
|---|---|
| Target vessel | |
| LM or LM + LAD | 7 (28%) |
| LAD | 13 (52%) |
| RCA | 5 (20%) |
| LCX | 0 |
| RVD, mm | 3.2 ± 0.5 |
| Lesion length, mm | 20 (7.2–58.0) |
| DS, % | 81.5 ± 7.8 |
| Bifurcation | 15 (60%) |
| SYNTAX score | 19.0 (6.0–49.0) |
| MVD | 8 (32%) |
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